Join Our Team

• Perform ECG, Vital Signs, obtain blood sample and study specific testing
• Obtain Medical History and Informed Consent from potential trial subjects
• Obtain Informed Consent as appropriate
• Explanation of the use of study drug(s)
• Dispense and Administer study drug(s)
• Receive physician’s medication order and administer medications from the crash cart
• Adverse Event Reporting
• Catheter insertion and removal
• Perform drug/cotinine screen and alcohol test
• Proper collecting, handling and processing of PK samples
• Monitor and maintenance of Crash Cart
• Cardiac Monitoring (Telemetry) (RN & Paramedic only)
• Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
• Maintain accurate, complete, legible and timely data entry
• Write and/or review source documentation forms
• Serve and/or monitor meals
• Performs other tasks and projects as assigned

• Education: RN with current registration with regulatory body in Ontario.
• Current BCLS/ ACLS & First Aid certification.
• Skills: Good interpersonal skills, good communication skills.
• Attentive to details, good initiative and able to work with changing priorities.
• Computer skills an asset.
• Ability to accommodate a flexible work schedule

• Enter and/or update potential volunteer information in the Recruitment Database
• Offer study participation and provide tentative study information to potential study volunteers
• Administer telephone questionnaires to potential study volunteers
• Book, reschedule and/or cancel medical screening appointment(s) for potential study volunteer(s)
• Perform screening reception duties including but not limited to ID verification, recording of Demographic information
• Build and maintain solid relationship with study volunteers by providing excellent customer service
• Resolve any volunteer related issues in a professional and timely manner
• Provide statistical reports to management e.g. month end report, study recruiting stats
• Participate in departmental meetings and assist management in implementing outlined departmental initiatives and developing strategies to maintain and increase subject retention
• Liaise with various departments regarding subject participation
• Help with main reception or clinic check-in as needed
• Direct calls, volunteers, couriers and visitors to the right person/department promptly
• Maintain screening related files
• Perform any other duties as required permissible by training and experience
• Conduct of procedures according to Protocol and applicable Good Clinical Practice (GCP) guidelines, applicable regulations and BioPharma Services Inc. Standard Operating Procedures (SOPs) at all times
• Ensure accurate and complete documentation of all clinic study source documents and/or forms according to company’s SOP, GCP and other guidelines
• Obtaining blood/urine samples, obtaining ECG, obtaining vital signs, processing of blood/urine samples for shipment to the appropriate clinical diagnostic laboratory, obtaining subject’s Height, Weight and Frame size
• Conducting a subject interview
• Setting up the clinic according to the study requirements (tube labeling, bed set up, photocopying, numbering of files, binding and archival of study files and supporting documents, etc.)
• Monitor and/or perform clinic activities (meal monitoring, water restriction, subject entrance and subject exit, etc.)
• Conducting pre-shipment sample inventories and preparing sample shipments
• Other duties as may be required & as training and experience allow

• Strong organizational, time management and planning skills to work independently with efficiency and accuracy
• Excellent interpersonal and public relation/customer service skills
• Strong team player with ability to multi-task in a fast-paced environment
• Experience in dealing with and handling confidential information
• Proficiency in English, with excellent oral and written communication skills
• Proficiency in Microsoft Word and Microsoft 2 year Medical Technology Diploma, or equivalent
• 1-2 years of recent phlebotomy and ECG experience
• A minimum of 1 year experience in a basic laboratory setting
• Flexible hours depending on business requirements including weekends

The statistical programmer performs all SAS programming tasks for clinical trial analysis, perform validation for internally developed SAS codes, implements the statistical analysis on the clinical study data, generates the study summary tables, data listings and graphs/figures (TLGs/TLFs) and performs quality control (QC) checks of the statistical outputs (TLGs/TLFs).

This position prepares clinical data from multiple sources, creates derived datasets, executes data specifications to transform clinical study data into Clinical Data Interchange Standards Consortium (CDISC)-compliant data sets (SDTM and ADaM), reviews SDTM specifications, and prepares ADaM specifications, define.xml, and works closely with teams to participate in the validation process of SAS programs on various clinical projects required.

• Write SAS codes for the creation of SDTM and ADaM datasets as per SDTMIG & ADaMIG for clinical study data
• Validate SDTM and ADaM datasets and create define.xml file
• Develop and debug simple to complex SAS programs in a timely manner to provide ad hoc flexible and rapid SAS programming
• Work with Biostatisticians to complete the validation of SAS programs on various clinical study data in accordance with validation plan and user requirements specifications as per SOPs
• Execute double programming for newly developed SAS codes and generation of TLFs
• Maintains documentation for SAS programs and validation results
• Perform statistical analysis of clinical trial data and generate statistical tables, graphs/figures, and listings for clinical trial data as per study protocol and statistical  analysis plan (SAP)

• Implement quality control (QC) tasks of the statistical outputs: (TLG/Fs) and the checks of SAS program as required according to SOPs

• Review study data reviewer’s guide and analysis data reviewer’s guide for submitted datasets as per regulatory guidance
• Review study protocols, SAP with mock shells, and clinical study report as assigned.
• Perform miscellaneous tasks as assigned

• Minimum BS (MS preferred) in Computer Science, Statistics, Biostatistics
• Experience at least 2 years in SAS programming including SAS/BASE, SAS/SQL and SAS/Macros in the pharmaceutical industry.
• Proficient in the Microsoft Office
• Knowledge and experience of CDISC
• Knowledge of FDA, EMA and Health Canada and ICH regulations and guidelines preferred
• Ability to work effectively as a member of a multidisciplinary research team
• Ability to work creatively and analytically in a problem-solving environment
• Ability to prioritize multiple projects and to work with tight deadlines while maintaining high standards
• Strong attention to detail
• Effective written and verbal communication skills
• Self-motivated and detailed-oriented

• Perform ECG, Vital Signs, obtain blood sample and study specific testing
• Obtain Medical History and Informed Consent from potential trial subjects
• Obtain Informed Consent as appropriate
• Explanation of the use of study drug(s)
• Dispense and Administer study drug(s)
• Receive physician’s medication order and administer medications from the crash cart
• Management and reporting of Adverse Events
• Catheter insertion and removal
• Perform drug/cotinine screening, alcohol testing and other procedures as required
• Proper collecting, handling, and processing of PK samples
• Monitor and maintenance of Crash Cart
• Cardiac Monitoring (Telemetry) (RN & Paramedic only)
• Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
• Maintain accurate, complete, legible and timely data entry
• Write and/or review source documentation forms
• Performs other tasks and projects as assigned

• Available any shifts between 06:00am – next day 06:00am (morning, afternoon or night shift)

• MOHLTC Advanced Care Paramedic (ACP) Certificate,
• Graduate of an Advanced Care Paramedic program through a recognized and accredited Community College or equivalent
• Current BCLS, ACLS & First Aid certification.
• Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
• Ability to accommodate a flexible work schedule

• Write and/or review final Clinical Study Report(s) in compliance with the internal SOPs and the guidance of different regulatory authorities (TPD, FDA, EMA, etc.).
• Ensure the writers’ compliance with different clients’ specifications for all the documents generated by the Medical Writing team.
• Conduct and maintain the required training for junior Medical Writers.
• Assist in the development of the document templates, relevant Standard Operating Procedures (SOPs) and guidelines.
• Work closely with clinical personnel and the Principal Investigator to ensure that clinical documents are produced to the standard required by Good Clinical Practice (GCP).
• Ensure accurate and complete documentation of all clinic study source documents and/or forms according to company’s SOP, GCP and other applicable guidelines.
• Conduct all work in compliance with SOP’s, GCP and to observe all regulatory guidelines.
• Negotiate timelines with external departments.
• Compile study documents, as required.
• Photocopy and scan study documents.
• Perform other work as assigned.

• Minimum university degree, B.Sc. (i.e. Life Sciences)
• At least 2 years of experience in CRO clinical study report writing, preferably of Phase I and Bioequivalence studies
• Good interpersonal and communication skills
• Attentive to details, good initiative and able to work with changing priorities

• Perform ECG, Vital Signs, obtain blood sample and study specific testing
• Obtain Medical History and Informed Consent from potential trial subjects
• Obtain Informed Consent as appropriate
• Explanation of the use of study drug(s)
• Dispense and Administer study drug(s)
• Receive physician’s medication order and administer medications from the crash cart
• Adverse Event Reporting
• Catheter insertion and removal
• Perform drug/cotinine screen and alcohol test
• Proper collecting, handling and processing of PK samples
• Monitor and maintenance of Crash Cart
• Cardiac Monitoring (Telemetry) (RN & Paramedic only)
• Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
• Maintain accurate, complete, legible and timely data entry
• Write and/or review source documentation forms
• Serve and/or monitor meals
• Performs other tasks and projects as assigned

• Education: RPN current registration with regulatory body in Ontario.
• Current ACLS, BCLS & First Aid certification.
• Good interpersonal skills, good communication skills.
• Attentive to details, good initiative and able to work with changing priorities.
• Computer skills an asset.
• Ability to accommodate a flexible work schedule

• Review draft and/or final Clinical Study Report(s) (CSRs) for various type of clinical trials including BE, BA, phase I – IV and human abuse potential clinical trials in compliance with the internal SOPs and the guidance of different regulatory authorities (TPD, FDA, EMA, ).
• Ensure accurate and complete documentation of all clinic study documents and/or forms according to company’s SOP, GCP and other applicable guidelines.
• Check reported values in the CSR against source and TLFs. Ensure consistency within the CSR.
• Work closely with CRCs, Medical Writer, clinic supervisors and QA department to ensure that clinical study reports and related documents are completed according to the standard required by Good Clinical Practice (GCP).
• Work closely with department management to improve the quality of the CSRs and maintain Quality Control System.
• Provide training to Medical Writer team according to the updated SOPs and/or regulatory guidance, if it is necessary.
• Conduct all work in compliance with SOPs, GCP and to observe all regulatory guidelines.
• Perform other activities within the department as needed.

• Minimum university degree, B.Sc. (i.e. Life Sciences);
• At least 3 years of Medical Writing
• Experience in an CRO environment, in the conduct of Phase I and Bioequivalence studies.
• Experience with current regulatory/ICH requirements on clinical study protocols and reports.
• Demonstrate analytical thinking with strong attention to details, good initiative, ability to work with changing priorities and effective time management.

The Pharmacokinetic Scientist is responsible for providing scientific expertise for the design, analysis, reporting, and presentation of pharmacokinetic data for various study designs such as BA/BE, 505 (b) (2), and Phase I studies. They also provide scientific support to the other company divisions and acts as a scientific consultant with the clients.

• Performs literature and data evaluation to provide scientific background for clinical studies design
• Prepares the PK portion of synopses for clinical studies
• Answers inquiries in process of preparation and reviews study protocols
• Performs/reviews pharmacokinetic analysis of concentration-time data with the up-to dated software such as WinNonlin
• Perform modeling analyses with PK software for PK level prediction or IVIVC
• Prepares the pharmacokinetic section of clinical study reports
• Interacts and provides input and feedback to Biostatistics Department for data analysis
• Reviews statistical output to evaluate study results
• Reviews study reports
• Provides scientific support to other departments and teams in the areas of pharmacology, pharmaceutics and pharmacokinetics
• Takes part in revision of the Pharmacometrics Department and the company SOPs; provides input into departmental practices and maintains updated the study- and report-related templates
• Maintains the Pharmacometric Department databases; provides the department and the company with updated scientific literature and maintains regulatory guidelines updated

• Minimum M.Sc in Pharmacy/Pharmacology or related field
• Minimum 2 year experience with clinical trials design/data analysis
• Expertise in the fields of pharmacology and pharmacokinetics and knowledge/experience of PK software such as WinNonlin
• Proficiency in the Pk/Stats softwares

• • Coordinating conduct of the clinical trials at BPSI. Primarily the type of trials assigned will be standard Bioequivalence studies
  • This includes but is not limited to:
  • With assistance lead all clinical aspects (excluding recruiting) of assigned Bioequivalence trials
  • Act as the point of contact for the clinical group for assigned trials when dealing with internal and external customers
  • Preparation of study related documentation
  • Review completion of study documents (Case Report Forms and Source Documents)
  • Perform clinical and study procedures as per study protocol as training and experience allows
  • Detailed review of subject and study documentation, case report form (CRFs) and source documents
  • Ensure the conduct of clinical trials according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and BioPharma Services Inc. Standard Operating Procedures (SOPs) at all times
  • Work with the QA group during Audits and Audit Follow-up and in the development/revision and implementation of Standard Operating for the Bioequivalence trials; ensure that the SOPs are consistent with GCP, and regulatory guidelines; review and update SOPs as required
  • Responsible for remaining current with regulatory requirements (TPD, FDA, etc.)
  • Participate in staff training sessions
  • Other duties as may be required & as training and experience allow

• Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience
• Certification in Clinical Research is an asset
• Flexible hours depending on business requirements
• Rotating shifts and weekend requirements
• 1+ years’ work experience as a CRC in a CRO (preferably in conducting Bioequivalence clinical trials)
• Excellent problem solving, communication, multitasking and interpersonal skills
• Excellent in Microsoft Word and Excel

• Coordinates, monitors and supervises all study activities to ensure proper execution of assigned clinical research trials (BE, Phase I, etc.) and to ensure that study protocols, BPSI SOPs, ICH-GCPs and regulatory requirements are met
• Act as a Leader by advising CRCs, Study Preparation Associates, Clinical Research Technicians, and Safety Staff on proper trial execution based on protocol, SOP, and regulatory requirements
• Conducts CRC and CRCA training.
• Meets and addresses issues with study monitors, sponsors and regulatory agencies as appropriate
• Respond to queries by internal departments on trial conduct
• Participates in review and development of study protocols, BPSI SOPs, and internal procedures
• Analyzes and develops action plans to address QA findings, including development of CAPA reports
• Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements
• Performs CRC, CRCA and/or Study Preparation Associate duties if required
• Maintains adequate, accurate, complete and legible records
• Detailed review of subject and study documentation, CRFs and source documents
• Conducts Protocol training for clinical research staff and Investigators.
• Works with QC and QA during audits and audit follow-ups
• Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
• Performs other tasks as assigned and as training and experience allow

• Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience.
• 3-5 years work experience as a Clinical Research Coordinator or similar role in a CRO (preferably in conducting Phase I/IIa clinical trials)
• Certification in Clinical Research is an asset.
• Flexible hours depending on business requirements.
• Rotating shifts and weekend requirements.
• Excellent problem solving, communication, multitasking and interpersonal skills
• Ability to work in a fast paced environment with a high degree of organization.
• Excellent in Microsoft Word and Excel.

Reporting to the VP, Digitization & Optimization, the Business Solutions Analyst is responsible for deploying and supporting key digital tools that optimize recruitment, screening, clinic and other business workflows. The role will provide business and technical support on key technology solutions used within the organization including the Recruitment Platform, Recruitment Call Centre Technology, Direct Data Capture system, Smartsheet and future technology solutions.

The role will be responsible for analyzing key business processes and leveraging technology solutions to drive operational efficiency while supporting the business in achieving their objectives. This role is responsible for developing efficient procedures and providing training while implementing new changes.

• Function as the Subject Matter Expert (SME) for the support of digital business tool systems including ClinicWave, Direct Data Capture, 8×8 and Smartsheet
• Analyze the work being done by the organization to identify ways in which it best can be served through digital tools.

• Work and interact with staff to understand their challenges and needs to determine how the software can better enhance business processes

• Recommend changes to established processes and methods; propose alternative and new solutions to improve operational efficiency

• Communicate with stakeholders to review data analysis and potential solutions.
• Assist with development and preparation of training tools, user manuals, and standard operating procedures.
• Keep up to date on enterprise business solution technology, clinical trial technology and best practices.
• Perform testing to validate system changes

• Assist in the development of report templates and documentation

• Test software in comparison to specifications and user requirements
• Work closely with management and vendors to help ensure the deliverables are met
• Provide training and end-user support during and after the implementation process
• Provide support for the BPSI staff in both Toronto and Missouri sites
• Assist in the development of templated reports for Commercial and Clinical Operations.
• Support the day-to-day end-user assistance and including troubleshooting and resolution after project launch
• Monitor the performance of digital business tools, identifying issues, system glitches and working to resolve them
• Provide on-call support as required and identify continuous process improvements
• Participate in various types of projects for process enhancements
• Assist in the creation of all documentation and user guides for the software and develop training programs and execute training for the various user groups and departments within BPSI
• Collaborate with QA Validation, vendors and Clinical teams to ensure all SOPs, validation reports, and other documentation are in line with industry standards related to EDC, 21 CFR Part 11, ICH-GCP.

• Bachelor’s Degree in Computer Science, Life Science, or related field.
• At least 3 – 6 years’ experience data management or working with software solutions is required.
• Knowledge of SQL programming is an asset
• Business intelligence (B.I.) dashboard and reporting skills are an asset
• Good verbal and written communication skills.
• Strong organizational and interpersonal skills.
• Ability to work independently and in a team-oriented environment.
• Knowledge of Microsoft Office, Salesforce, Smartsheet, and other software clinical trial technologies is an asset.
• Ability to analyze data using statistical software according to strict timelines.
• Project management skills.
• Adherence to Good Clinical Practice (GCP) and other regulatory practices and laws.

• Ensure all study-related activities are performed in compliance with Protocol, BPSI SOPs, and regulations
• Ensure all prepared study source documents and/or forms are in accordance to protocols, SOPs, and regulations
• Ensure that all study-related documentation is reviewed to confirm the quality, reliability, accuracy, completeness and consistency in accordance with Protocols, SOPs, GCP guidelines, and applicable regulatory requirements, as well as, adhere to the established timelines
• Review all other study-related documentation: medical screening files, pharmacy labels, and files
• Ensure the conduct of clinical trial according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and BPSI SOPs at all times
• Work closely with CRCs to ensure studies are conducted properly with high quality and high efficiency
• Observe, on a random basis, clinical procedures during the conduct of studies, sample bundling, and shipping process
• Provide reports of the reviewed data to relevant personnel/department
• Develop and utilize QC Checklist or other QC tools designed to document the QC review process
• Assist with training of new QC Staff
• Participate in the review of SOPs and Protocols
• Performs other tasks and projects as assigned

• Post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
• 1+ year of relevant clinical research experience, knowledge of ICH-GCPs, and professional experience working in CRO is an asset
• Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.
• Excellent attention to detail
• Excellent communication skills
• Excellent computer skills
• Certification in Clinical Research is an asset.

• Undergraduate degree in sciences or equivalent
• 1 – 2 years’ experience in a customer service environment and/or call center
• 1-year work experience in a CRO an asset
• Previous sales experience preferred
• Strong organizing and planning skills to work independently with efficiency and
accuracy
• Excellent interpersonal and public relation skills
• Demonstrated proficiency in English, with excellent oral and written
communications skills
• Decisive, good decision-making skills, able to escalate response to situations
when relevant

Reporting to the VP Global Clinical Operations the Director, Clinical Operations St. Louis Operations is responsible for the execution of the Global aspects of St. Louis trials. General Manager St. Louis Operations will be responsible for the:

• Manage the operational aspects of clinical studies and operational expenses for the St. Louis Missouri U.S.A. Facility.
• Meet expectations of corporate goals, timelines, cost and quality performance.
• The General Manager St. Louis Operations will oversee the planning, development, implementation, execution, and management of assigned clinical trials, as well as participate in other areas requiring scientific/technical expertise.

• Increase management’s effectiveness by recruiting, selecting, orienting, training, coaching, counseling, and disciplining managers; communicating values, strategies, and objectives; assigning accountabilities; planning, monitoring, and appraising job results; developing incentives; developing a climate for offering information and opinions; providing educational opportunities
• Develops strategic plan by studying technological and financial opportunities; presenting assumptions; recommending objectives.
• Accomplishes subsidiary objectives by establishing plans, budgets, and results measurements; allocating resources; reviewing progress; making mid-course corrections.
• Coordinates efforts by establishing procurement, production, marketing, field, and technical services policies and practices; coordinating actions with corporate staff.
• Builds company image by collaborating with customers, government, community organizations, and employees; enforcing ethical business practices.
• Maintains quality service by establishing and enforcing organization standards.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
• Contributes to team effort by accomplishing related results as needed.
• Ensures clinical trial activities are carried out by adhering to the policies, study protocols, SOPs, GCP and ICH requirements and pertinent regulations
• Directs and supervises all clinical Leads and assigned staff members
• Responsible for providing support and guidance to the various clinic teams and to coordinate all operational activities of the clinic
• Plans, organizes, manages and monitors the clinic activities/operations in order to achieve the expected results.  Ensures that high-quality customer service is offered by all clinic employees
• Assess performance of direct reports and other team members and establish goals and development plans with the clinic staff
• Write SOPs, policies and rules to conduct phase 1 and bioequivalence clinical studies.
• Participates in strategic decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget
• Maintains current professional knowledge base of clinical research methodologies and regulatory requirements
• Interacts with Study Monitors, investigators, regulators, vendors, and others external to the Company
• Serves as a key interface with Project Management with regard to budget, resources, priorities, strategy, and time lines.
• Participates on Safety Committee, Protocol Review Committee, Inter-departmental meetings
• Actively analyze and develop action plans to address issues brought up by QA, Study Monitors, sponsors and regulatory agencies
• Performs other tasks and projects as assigned

• Nine or more years’ experience in clinical trials, five years in a management role and at least 4 years of relevant experience in a Clinical Research Organization
• Significant experience managing Phase I-IIb, Bioavailability and Bioequivalence studies
• Degree in Health Sciences or related discipline
• CCRP certification
• Computer literacy and excellent communication skills

• Perform ECG, Vital Signs, obtain blood sample and study specific testing
• Obtain Medical History and Informed Consent from potential trial subjects
• Explanation of the use of study drug(s)
• Dispense and Administer study drug(s),
• Receive physician’s medication order and administer medications from the crash cart
• Adverse Event Reporting
• Catheter insertion and removal
• Perform drug/cotinine screen and alcohol test
• Serve and/or monitor meals
• Obtain body measurements including height and body weight, and calculate Body Mass Index (BMI).
• Monitor and maintenance of Crash Cart
• Cardiac Monitoring (Telemetry) (Nurse & Paramedic only)
• Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
• Maintain accurate, complete, legible and timely data entry
• Perform any other duties as required by Supervisor

• Registered Nurse with current registration with regulatory body in Missouri.
• Working experience in Clinical Research setting preferred
• Working knowledge of Good Clinical Practice preferred
• Current BCLS/ ACLS & First Aid certification.
• Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
• Ability to accommodate a flexible work schedule

• Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
• Perform ECG and Vital Signs
• Collect/process blood and urine samples as well as other specimens as required.
• Perform drug/cotinine screen and alcohol test as well as urine pregnancy test.
• Obtain body measurements, including height and body weight, and calculate Body Mass Index (BMI).
• Proper collecting, handling, and processing of PK samples
• Process and ship lab samples
• Assist in drug administration by performing hand and mouth check
• Serve and/or monitor meals
• Maintain accurate, complete, legible and timely data entry
• Perform screening reception duties as required, including but not limited to ID verification, recording of demographic information
• Perform data review of the source and/or other related documents as required.
• Perform any other duties as required by Group Leader, Manager, Designee

• CPR & First Aid certification preferred
• Phlebotomy certification preferred
• Flexible hours depending on business requirements.
• Rotating shifts and weekend requirements

• Enter and/or update potential volunteer information in the Recruitment Database 
• Offer study participation and provide tentative study information to potential study volunteers 
• Administer telephone questionnaires to potential study volunteers 
• Book, reschedule and/or cancel medical screening appointment(s) for potential study volunteer(s). 
• Perform screening reception duties as required, including but not limited to ID verification, recording of Demographic information (Medical Screening staff only).  

• Build and maintain solid relationship with study volunteers by providing excellent customer service 
• Resolve any volunteer related issues in a professional and timely manner 
• Provide metrics on advertisement, performance and recruitment activities 
• Provide statistical reports to management e.g. month end report, study recruiting stats 
• Participate in departmental meetings and assist management in implementing outlined departmental initiatives and developing strategies to maintain and increase subject retention 
• Perform any other duties as required permissible by training and experience

• A minimum Grade12 high school diploma, college diploma preferred  
• 1-2 years’ experience in a customer service, call center environment 
• Strong knowledge of medical terminology an asset 
• Strong organizational, time management and planning skills to work independently with efficiency and accuracy 

• Excellent interpersonal and public relation/customer service skills 
• Strong team player with ability to multi-task in a fast-pace environment 
• Experience in dealing with and handling confidential information 
• Proficiency in English, with excellent oral and written communication skills 
• Proficiency in Microsoft Word and Microsoft Excel 

• Directs and supervises all clinical leads and assigned staff members
• Lead and coach the team to ensure proper planning, organization and execution of clinical research studies.
• Ensures clinical trial activities are carried out by adhering to the policies, study protocols, SOPs, GCP and ICH requirements and pertinent regulations.
• Responsible for providing support and guidance to the various clinic teams and to coordinate all operational activities of the clinic.
• Plans, organizes, manages and monitors the clinic activities/operations in order to achieve the expected results, ensuring that high-quality customer service is offered by all clinic employees.
• Assess performance of direct reports and other team members and establish goals and development plans with the clinic staff.
• Write SOPs, policies and rules to conduct phase 1 and bioequivalence clinical studies.
• Participates in strategies decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget.
• Maintains current professional knowledge base of clinical research methodologies and regulatory requirements.
• Interacts with Study Monitors, investigators, regulators, vendors and other external to the Company.
• Serves as a key interface with Project Management with regard to budget, resources, priorities, strategy, and time lines.
• Participates on Safety Committee, Protocol Review Committee, Inter-departmental meetings.
• Actively analyze and develop action plans to address issues brought up by QA, Study Monitors, sponsors and regulatory agencies.
• Performs other tasks and projects as assigned.

• Minimum two (2) years’ experience in clinical research and at least two (2) years of relevant experience in a CRO environment
• CCRP Strong Preferred
• Extensive experience managing Phase I-II Bioavailability and Bioequivalence studies
• Degree in Health Sciences or related discipline, preferred
• Computer literacy and excellent communications skills

Perform all delegated/assigned recruiting tasks in compliance with study protocol, SOPs, GCP and regulatory requirements.

• Maintain up-to-date knowledge of study information and study planning strategies
• Assist Manager/Director to maintain up-to-date knowledge of competition and industry trends
• Collaborate with Manager/ Director in the development of recruitment strategies for various segments of the population and ensure that an adequate number of suitable volunteers are recruited for all studies
• Conduct regular communication of goals, priorities, and studies with Clinical Contact Centre Representatives to keep staff informed of daily objectives and study enrolment status
• Changes from scheduled timelines or recruitment challenges are communicated in a timely manner to mitigate risks associated with study enrolment
• Manage the tasks of the Clinical Contact Centre Representatives including acknowledgment of Study Briefings, updating the clinical database, responding to inbound calls, and booking appointments
• Organize, oversee, and conduct clinical staff training
• Assist Manager/Director to do performance reviews and coaching
• Write, Revise, and approve internal procedures
• Participates in protocol review and development
• Enter and/or update potential volunteer information in the Recruitment Database
• Generate recruitment highlights (protocol summary)

• Ensures that the volunteer’s study participation history; washout and lockout dates as per Clinical RSVP (cRSVP) are verified and cleared prior to study admission.

• Offer study participation and provide tentative study information to potential study volunteers
• Administer telephone questionnaires to potential study volunteers
• Look, reschedule and/or cancel medical screening appointment(s) for potential study volunteer(s).

• Populates the study-specific details into ClinWave (including all pertinent details including but not limited to the study drug/ study demographics/ stipends/ referral fees/ screening allocations/ study-specific inclusion & exclusions etc…)

• Build and maintain solid relationship with study volunteers by providing excellent customer service
• Resolve any volunteer related issues in a professional and timely manner
• Provide metrics on advertisement, performance, and recruitment activities
• Provide statistical reports to management e.g., month end report, study recruiting stats
• Participate in departmental meetings and assist management in implementing outlined departmental initiatives and developing strategies to maintain and increase subject retention

• Perform any other duties as required permissible by training and experience

• Undergraduate degree in sciences or equivalent
• 2 – 4 years’ experience in a customer service environment and/or call center
• At least 2-3 years’ work experience in a CRO an asset
• Strong organizational, time management and planning skills to work independently with efficiency and accuracy
• Strong team player with ability to multi-task in a fast-paced environment
• Excellent interpersonal and customer service skills
• Experience in dealing with and handling confidential information
• Decisive, good problem-solving skills, able to escalate response to situations when relevant
• Demonstrated proficiency in English, with excellent oral and written communications skills
• Proficient in Microsoft Word and Microsoft Excel

As a Junior Desktop Support Analyst, you will report to the Director of Corporate IT, as well as work closely with the information technology department.

• Troubleshoot and resolve support issues from various support channels (phone calls, chats, self service tickets); document and escalate issues further as
• Record all incident tickets under the appropriate severity into the ticket tracking
• Install, troubleshoot, patch and replace end user IT workplace equipment (pc, printers, smartphones, peripherals, etc.)
• Manage local servers and networks in collaboration with Corporate IT team
• Maintain an up-to-date inventory of all IT Assets (Hardware and Software)
• Provide support for audio-visual setups, system hardware and connectivity issues
• Provide technology training to new hires, either in-person or virtually through online sessions
• Provide support for telecom issues as required
• Participate in various corporate IT projects and support issues as required
• Assist in technology specific research and stay up-to-date with technology trends
• Willing to work a permanent shift 3x a week between Monday to Friday
• Provide an in-person support to BioPharma St. Louis facility
• Participate in the after-hours on-call schedule if needed

• Minimum 1 year of experience and post-secondary education in an IT-related field of study
• Microsoft Windows 10, Mac OS, Google Workspace, and Office 365 experience
• Experience in creating scripts/macros in a language such as Python.
• Experience in troubleshooting Network issues
• Ability to lift/move equipment/boxes up to 40lbs

First point of contact for visitors and callers to BPSI and to undertake a range of administrative duties.  As the “face” of our company, you will ensure visitors receive a heartwarming welcome by providing professional and friendly service.

Office Administrative Coordinator is able to identify and address the needs of senior managers and perform administrative tasks to ensure our company’s workflow runs smoothly.

Provide high-quality administrative and clerical assistance to senior management.  The Office Administrative Coordinator main duties are outlined below As an Office Administrative Coordinator, you should combine a pleasant personality with a dynamic professional attitude. Our ideal candidate can deal efficiently with complaints and has a solid customer service approach.

This role has a strong focus on schedule coordinating for our clinic. The ideal candidate will be highly detail oriented and working with management to efficiently and effectively generate, communicate, and manage schedules as per business needs.

Reception:

• Greet visitors, manage phone calls on company switchboard and emails in a professional manner
• Check company voicemail, and transfer to appropriate person in a timely manner
• Tracking and monitoring access cards and maintaining sign in logs
• Sorting/distribution of incoming and outgoing correspondence

Administrative:

• Ordering office supplies and managing inventory
• Respond promptly to managers’ queries
• Performs any other reasonable assignments given by the Department Management or his/she designates

Shipments – Outgoing/Incoming:

• Schedules transportation requirements including shipment notification, tracking and proof of delivery (FedEx, Purolator, and occasionally world courier)
• Compares identifying information and counts items of outgoing shipments to verify information against bills of lading, invoices, orders, or other records
• Verifying and accepting deliveries and coordinating distribution

Scheduling

• Coordinate and/or prepare the technical team activities, scheduling, task assignment, vacation request and replacements
• Review scheduling and availability of Clinical Operations Staff
• Create study tasks list reflecting procedures required by study protocols and internal SOP’s
• Assist in the organization of training programs including SOP, GCP training, regulatory requirements, and other pertinent in-house training modules
• Liaison with Managers, and Group leaders to keep track of attendance and/or changes in schedule

• 2 years Customer Service experience
• 1 year of supply ordering and inventory control experiences
• 1 year of Schedule Coordination
• College Diploma or Degree from a recognized University related to Business Administration
• Fluent in written and spoken English with strong communication skills (via phone, email, and in-person) handling customer requests or challenges
• Available to occasionally work on weekends
• Proficient in office management systems, MS Office, online calendars, knowledge of office procedures and experience using office tools including printers/copiers and fax machines
• Professional attire / appearance and manners
• Organizational, planning, and multitasking skills with strong attention to detail
• Able to work under pressure, action oriented and self-motivated with a demonstrated commitment to work as part of a team and independently

Manager, Clinical Operations is responsible for the conduct of clinical research studies at BioPharma Services Inc. ensuring compliance with study protocol, SOPs, GCPs and regulatory requirements as well as adherence to the assigned timelines.  The Manager will oversee the planning, development, implementation, execution, and management of assigned clinical trials, as well as participate in other areas requiring scientific/technical expertise, including regulatory submissions.

• Lead and coach the team to ensure proper planning, organization and execution of clinical research studies.
• Ensures clinical trial activities are carried out by adhering to the policies, study protocols, SOPs, GCP and ICH requirements and pertinent regulations.
• Responsible for providing support and guidance to the various clinic teams and to coordinate all operational activities of the clinic.
• Plans, organizes, manages and monitors the clinic activities/operations in order to achieve the expected results, ensuring that high-quality customer service is offered by all clinic employees.
• Assess performance of direct reports and other team members and establish goals and development plans with the clinic staff.
• Write SOPs, policies and rules to conduct phase 1 and bioequivalence clinical studies.
• Participates in strategies decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget.
• Maintains current professional knowledge base of clinical research methodologies and regulatory requirements.
• Interacts with Study Monitors, investigators, regulators, vendors and other external to the Company.
• Serves as a key interface with Project Management with regard to budget, resources, priorities, strategy, and time lines.
• Participates on Safety Committee, Protocol Review Committee, Inter-departmental meetings.
• Actively analyze and develop action plans to address issues brought up by QA, Study Monitors, sponsors and regulatory agencies.
• Performs other tasks and projects as assigned.

• Minimum two (2) years’ experience in clinical research and at least two (2) years of relevant experience in a CRO environment
• Extensive experience managing Phase I-II Bioavailability and Bioequivalence studies
• Degree in Health Sciences or related discipline, preferred
• Computer literacy and excellent communications skills