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OUR CURRENT CAREER OPPORTUNITIES

Want to be inspired?

As an Essential Service Provider, our positions remain open and available

Seeking highly motivated, innovative thinking, medical and scientific professionals.

With an emphasis on personal growth and development, BioPharma Services strives to create an environment where our people matter.  To provide excellence by inspiring enhanced performance to advance medical research and creating a team to drive results.  We take pride in the work we do and welcome all individuals that want to join our dynamic culture and be a part of our brand.

Review our currently available opportunities and explore the possibility of becoming a part of our community of Clinical Research Professionals.

Toronto, Ontario - Quality Assurance Auditor, Clinical

Position Summary: The Quality Assurance Auditor is responsible for planning, conducting and reporting quality assurance audits as scheduled. The QA Auditor supports QA Management in promoting and assessing compliance of clinical and non-clinical studies with applicable regulations, guidelines, study protocols, study plans and company SOPs. This position directly reports to the Associate Director, Quality Assurance.   Duties and Responsibilities:
  • Perform audits of clinical trials for compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, Health Canada, EMEA, etc.)
  • Review Protocols and Informed Consent Forms (ICF)
  • Audit pre-study documentation, in-process activities, end-of-study documentation, clinical databases and clinical study reports.
  • Conduct various corporate audits, including audits of equipment maintenance, training records and computer validation.
  • Keep Management up to date with findings and follow up on corrective actions.
  • Assist in the review, writing and distribution of SOPs.
  • Assist QA management in hosting sponsor and regulatory audits/inspections.
  • Train other QA staff on tasks/activities specified by QA management
  • Assist QA management in the training of BPSI staff on SOPs and GCPs/GLP.
  • Coordinate and interact with other departments to ensure corporate, departmental and project goals are met.
  • Perform other relevant tasks delegated by QA management.
Qualifications:
  • University degree in a scientific area, or equivalent.
  • 1-2 years QA experience, preferably including audits of Phase 1 and/or BA/BE studies.
  • Excellent working knowledge of ICH guidelines, GCP, FDA regulations and guidelines, HPFB guidelines, and Canadian Food and Drugs Act.
  • Experience writing and reviewing Standard Operating Procedures (SOPs).
  • Excellent hand-eye coordination, organization, multi-tasking, communication and interpersonal skills.
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Clinical Research Technician

Duties and Responsibilities:
  • Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
  • Perform ECG and vitals
  • Compliance check on subjects
  • 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).
  • Catheter insertion and removal
  • 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 (Medical Screening staff only).
  • Perform data review of the source and/or other related documents as required.
  • Write and/or review source documentation forms
  • Conduct clinical staff training
  • Performs other tasks and projects as assigned
Qualifications:
  • 2 year Medical Technology Diploma, or equivalent
  • 1-2 years work experience in a CRO (preferably in conducting Phase I /Bioequivalence clinical trials)
  • 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.
  • Rotating shifts and weekend requirements
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Study Preparation Associate

Position Summary: Responsible for the preparation of all study related documents to ensure the quality, reliability, accuracy, completeness and consistency according to Protocol, SOPs and regulatory requirements. Other responsibilities as assigned.   Duties and Responsibilities:
  • Responsible for the accurate and timely preparation and maintenance of all study related source documents, including creation of study specific forms in paper and electronic format
  • Ensures the accuracy, timely and organized completion of assigned tasks within the Clinic in adherence to and compliance with the study protocol, SOPs, GCP and all regulatory requirements
  • Responsible for the creation and maintenance of Sponsor requested source documents
  • Maintains accurate, complete, legible and timely records
  • Participates in the development of internal staff training programs
  • Assists with the preparation and maintenance of Clinic related documents for the Regulatory Binder
  • Ensures the maintenance of Bio Centre/Administration fax, printer and photocopy equipment
  • Performs other tasks as assigned and as training and experience allow
Qualifications:
  • College diploma in science or business administration preferred but not required
  • Excellent computer skills (e.g. MS excel, word, etc)
  • Excellent organizational skills with attention to details
  • Proven track record of attendance
  • Knowledge of ICH-GCPs and professional experience working in CRO preferred
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Senior Clinical Research Coordinator

Duties and Responsibilities:
  • 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
  Qualifications:
  • 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.
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Quality Control Data Reviewer

Position Summary: Responsible for reviewing of all study related documentation to ensure the quality, reliability, accuracy, completeness and consistency according to Protocol, SOPs and Regulatory requirements. Other responsibilities as assigned.   Duties and Responsibilities:
  • Review study files after completion and ensure that they are accurate and legible according to protocol, SOPs and regulations
  • Ensure all prepared study source documents and/or forms are in accordance to protocols, SOPs and regulations
  • Review all other study related documentation: medical screening files, pharmacy labels and files including review of data entry from source documents.
  • Work closely with CRCs to ensure studies are conducted properly with high quality and high efficiency
  • Observe, on the random basis, clinical procedures during the conduct of studies, sample bundling and shipping process
  • Provide reports of the reviewed data to relevant personnel/department
  • Performs other tasks and projects as assigned
  • Develop and utilize QC Checklist or other QC tools designed to document the QC review process
  • Assist with training of new QC Data Reviewer Staff
  • Participate in review of SOP’s and Protocols
  • Ensure the conduct of clinical trial according the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and Biopharma Services Inc SOP’s at all times (copied from CRC’s responsibility)
  Qualifications:
  • Post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
  • 1-2 years of relevant clinical research experience, knowledge of ICH-GCPs and professional experience working in CRO
  • Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.
  • Excellent communication skills
  • Excellent computer skills
  • Certification in Clinical Research is an asset.
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Medical Assistant

Position Summary: To monitor subject safety while they are in confinement, in compliance with the study protocols, SOP’s regulatory requirements and fulfill business needs of the company.   Duties and Responsibilities:
  • 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
Qualifications:
  • Education: current registration with regulatory body in Ontario.
  • Current 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
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Phase I-Clinical Trial Documentation Specialist

Position Summary: The Phase I-Clinical Trial Documentation Specialist is responsible for overseeing the development and improvement of applicable documentation processes. The Phase I-Clinical Trial Documentation Specialist is also responsible for preparing the clinical trial documentation in the Investigator Site File (ISF) and in the Trial Master File (TMF) for Phase I studies. Furthermore, the Phase I-Clinical Trial Documentation Specialist submits and interacts with the Research Ethics Board (REB) for Phase I studies. Duties and Responsibilities:
  • Leads the development and refinement of applicable documentation systems and processes
  • Prepares an ISF and/or TMF, as applicable, for Phase I studies and collaborate with clinic staff to file the essential documents in the ISF and/or TMF for Phase I studies
  • Coordinates, prepares, and submits appropriate documents to the Research Ethics Board for review and approval (e.g., Protocol, Investigators Brochures, Informed Consent Forms, Telephone screens, subject information sheets, and advertisements) for Phase I studies
  • Serves as the administrative liaison with the Research Ethics Board for Phase I study-related submissions
  • Submits revised and additional materials to the Research Ethics Board (e.g. amendments, advertisements, safety/study status updates, and close out reports) as required for Phase I studies
  • Reviews and files approval documentation from the Research Ethics Board in the ISF and/or TMF and on the Study Specific Directory for Phase I studies
  • Prepares the Regulatory documents (Qualified Investigator Undertaking, FDA 1572, financial disclosure, etc.) and provides the completed documents to Sponsor/CRO for Phase I studies
  • Compile study documents for Phase I studies
  • Mentor, guide and assist junior member of the clinical documentation team for Phase I study-related documentations, as needed.
  • Establishes an electronic file structure for each clinical trial for use by clinical study team members
  • Assess and implements process and creates Standard Operating Procedures (SOP) for Phase I documentations
  • Perform other duties as required.
Qualifications:
  • BSc, BA, or equivalent experience
  • 5-10 years of administrative experience in clinical trials, with experience in Research Ethics Boards, ISF and TMFs
  • Experience with working, mentoring and managing individuals
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Senior Statistical Programmer

Position Summary: The Senior Statistical SAS Programmer is responsible for the development of SAS codes to create CDISC-compliant data sets (SDTM and ADaM), client-defined analysis datasets, and for the development of SAS code to generate Tables, Listings and Graphs/Figures (TLGs/TLFs) as well as integrated summaries of safety (ISS) and efficacy (ISE), ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, and programs. The Senior Statistical SAS Programmer  provides technical support and planning to develop the SAS macros and oversee the implementation of SAS codes and independently performs the statistical analysis on the clinical study data as outlined in the Clinical Study Protocol and /or Statistical Analysis Plan (SAP), and quality control (QC) checks for TLGs/TLFs. In addition, the qualified individual reviews the clinical study protocol and clinical study report as well as involves in the development of SAP, and works closely with Biostatistician to participate in the validation process of SAS programs on various clinical projects required and works with other teams (PK, Clinical Data Management, Medical Writing) to lead a team of programmers to manage timelines and deliverables.     Duties and Responsibilities:
  • Provide technical support and planning for the development of SAS codes or as per specified in protocol and SAP or the client requires
  • Review data standardization plan, SDTM data specifications, and a study data reviewer’s guide for submitted datasets as per regulatory guidance
  • Prepare ADaM dataset specifications as per required
  • Develop and validate SAS codes for the creation of CDISC datasets (SDTM and ADaM) according to approved datasets specifications for clinical study data
  • Validate SDTM and ADaM datasets and create define.xml file
  • Prepare analysis data reviewer’s guides (ADRG), define.xml and document the CDISC package (programs, validator report, datasets, define.xml, ADRG) for submission purpose
  • Provide training and technical guidance to Statistical Programmers
  • Write and validate SAS codes for the analysis of clinical study data to generate the  complete and accurate statistical tables, listings and graphs/figures (TLGs/TLFs) in according with the study protocol, SAP, and well-defined formats
  • Implement quality control (QC) tasks for the statistical outputs: (TLGs/TLFs) and the QC checks of SAS program as required according to SOPs
  • Review the clinical study protocol and clinical study report as assigned
  • Review SAP and prepare mock shells as required
  • Debug the complex issues of SAS codes in a timely manner to provide ad hoc flexible and rapid SAS programming
  • Work with team to complete the validation of SAS programs on various clinical study data in accordance with validation plan and user requirements specifications as per SOPs
  • Create randomization scheme for clinical studies as needed
  • Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with SOPs and/or clinical trial sponsor’s specific requirements
  • Perform miscellaneous tasks as assigned
  Qualifications:
  • Sc or M.Sc in Computer Sciences, Mathematics, Statistics/Biostatistics, relevant experience with SAS/Base, SAS/Macro, SAS/SQL and SAS/Graph
  • Strong SAS hands-on programming skill in the generation of tables, listings, and figures for clinical trials
  • At least 4-year experience with proven SAS skills in clinical trial analysis, CDISC and reporting
  • Excellent organizational skills and ability to delegate and prioritize work to meet tight deadlines while maintaining high standards
  • Proficiency with Microsoft Office
  • Solid knowledge of clinical drug development process and knowledge of FDA and other regulatory requirements and ICH/GCP guidelines and CDISC requirements
  • Full knowledge and understanding of the processes and procedures used within a statistical programming environment
  • Ability to establish and maintain effective working relationships with co-workers, managers, and clients
  • Good interpersonal skills and communication skills
  • Attentive to details, good initiative and able to work with changing priorities
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Senior Biostatistician

Position Summary: The Senior Biostatistician who will be responsible for application of statistical methods, providing statistical inputs, modifications of SAS codes, validation of SAS codes for clinical study data and generation of Tables, Listings and Graphs as outlined in the Clinical Study Protocol and Data Analysis Plan. The Senior Biostatistician will review clinical study protocol and clinical study report as well as work with PK/PD scientists for the development of the Statistical Analysis Plan and SOPs related to Biostatistics activities. Also, the Senior Biostatistician needs to interact with internal teams and external sponsors, auditors and clients.     Duties and Responsibilities:
  • Provide statistical inputs on study projects, especially in the field of statistical methodologies in study design, sample size estimation, statistical modeling, data handling, analysis and reporting
  • Work with Biostatistics team to develop and validate SAS codes for the analysis of clinical study data, generate output tables, listings and graphs in according with the study protocol and the statistical analysis plan (SAP)
  • Work with PK/PD scientists to prepare SAP
  • Generate randomization scheme for clinical studies
  • Provide technical advice to junior Biostatisticians as well as Statistical Programmers assigned to the program/projects.
  • Work with PK/Biostatistics team to prepare and review SOPs
  • Review statistical outputs and clinical study report
  • Work with Data Management team to provide inputs for the specifications of domains and the creation of CDISC ADaM datasets
  • Provide statistical consultations to the clients
  Qualifications:
  • M.Sc in Statistics or Biostatistics, experience with SAS/Base, SAS/Macro, SAS/SQL and SAS/Graph
  • Strong experience with statistical methods and modeling
  • At least 3 years of Biostatistician experience in the pharmaceutical industry or in the field of clinical research is required
  • Proficiency with Microsoft Office
  • Good interpersonal skills, good communication skills
  • Attentive to details, good initiative and able to work with changing priorities
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Statistical Programmer

Position Summary: 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.       Duties and Responsibilities:
  • 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
  Qualifications:
  • 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
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Pharmacokinetic Scientist

Position Summary:
      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 and Phase I studies. They also provide scientific support to the other company divisions and acts as a scientific consultant with the clients.
Duties and Responsibilities:
     
  • 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
  • Prepares/reviews the pharmacokinetic section of 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 Biopharmaceutics Department and the company SOPs; provides input into departmental practices and maintains updated the study- and report-related templates
  • Maintains the Biopharmaceutics Department databases; provides the department and the company with updated scientific literature and maintains regulatory guidelines updated
Qualifications:
     
  • At least M.Sc in Pharmacy/Pharmacology or related field plus minimum 2 year experience with clinical trials design/data analysis
  • Expertise in the fields of pharmacology and pharmacokinetics
  • Proficiency in the Pk/Stats softwares
  • Proven abilities in literature evaluation, scientific and medical writing and scientific support
  • Demonstrated analytical thinking with strong attention to detail
  • Good organizational skills and ability for multitasking and prioritization
  • CRO experience is asset
  If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Registered Nurse

POSITION SUMMARY:

To monitor subject safety while they are in confinement, in compliance with the study protocols, SOP’s regulatory requirements and fulfill business needs of the company.

Duties and Responsibilities:

  • 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
  • Qualifications:

  • 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
  • Please send your application to resumes@biopharmaservices.com

    St. Louis, Missouri - QC Data Reviewer

    Position Summary: Responsible for reviewing of all study related documentation to ensure the quality, reliability, accuracy, completeness and consistency according to Protocol, SOPs and Regulatory requirements. Other responsibilities as assigned.   Duties and Responsibilities:
    • Review study files after completion and ensure that they are accurate and legible according to protocol, SOPs and regulations
    • Ensure all prepared study source documents and/or forms are in accordance to protocols, SOPs and regulations
    • Review all other study related documentation: medical screening files, pharmacy labels and files, final report tabulations and PK STAT input and output as assigned
    • 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
    • Perform other duties as assigned by supervisor
      Qualifications:
    • Post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
    • 1-2 years of relevant clinical research experience, knowledge of ICH-GCPs and professional experience working in CRO
    • Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.
    • Excellent communication skills
    • Excellent computer skills
    • Certification in Clinical Research is an asset.
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - PRN Paramedic

    Position Summary:  To monitor subject safety during confinement in compliance with the study protocols, SOPs, and regulatory requirements while fulfilling the business needs of the company.   Duties and Responsibilities:
    • 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
    • Serve and/or monitor meals
    • 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) (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
      Qualifications:
    • Paramedic with current registration with regulatory body in Missouri.
    • Knowledge in Clinical Research and Good Clinical Practice a plus
    • Current BLS and ACLS certifications
    • 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
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - PRN Registered Nurse

    Position Summary: To monitor subject safety during confinement in compliance with the study protocols, SOPs, and regulatory requirements while fulfilling the business needs of the company. Duties and Responsibilities:
    • 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
    • IV Catheter insertion and removal
    • Monitor, assess, and document assessment of peripheral IV insertion and phlebotomy sites
    • 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
    Qualifications:
    • Registered Nurse with current registration with regulatory body in Missouri or a current NLC/eNLC multistate license
    • Knowledge in Clinical Research and Good Clinical Practice a plus
    • Current BLS and ACLS certifications
    • Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset
      Work Hours:
    • Ability to accommodate a flexible work schedule – on an “as-needed basis”
    • No guaranteed minimum hours
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - Group Leader

    Position Summary: The Group Leader is responsible for providing support, guidance and training to the clinical research team and to coordinate operational activities of a study within the department. The Group Leader is responsible for all activities related to direct supervision of staff. Duties and Responsibilities:
    • Oversees the execution of clinical trials
    • Provide input to the clinic calendar
    • Review scheduling of Clinical Research Staff
    • Responsible for monitoring of study activities
    • Coordinate all study activities to ensure protocol and regulatory requirement(s) are being met. (e.g. sample collection, sample processing, clinic set-up, drug administration etc.)
    • Provide protocol training for clinical research staff
    • Perform ECG, Vital Signs, Collect Routine Safety Labs
    • Obtain Informed Consent as appropriate
    • Complete compliance check on subjects as appropriate
    • Adverse Event Reporting and Serious Adverse Event reporting to appropriate department(s) as appropriate
    • Proper collection, handling and processing of Pharmacokinetic (PK) sample(s)
    • Maintain study files for each clinical trial and completion of Case Report Forms
    • Write, review and/or approve source documentation forms as appropriate
    • Maintain adequate, accurate, complete and legible records
    • Perform other tasks/duties as assigned by Supervisor
      Qualifications:
    • CPR certification is preferred
    • Knowledge of good clinical practice
    • At least 2 years’ experience in clinical research or relevant field preferred
    • Computer literacy: Microsoft Office. Good communication skills, problem solving, organizational and leadership skills
    • Relevant previous supervisory and training experience required
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - Clinical Research Recruiter

    Position Summary: Perform all delegated/assigned recruiting tasks in compliance with study protocol, SOPs, GCP and regulatory requirements.     Duties and Responsibilities:
    • 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
    Qualifications:
    • 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
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - Phlebotomist/Clinical Research Technician

    Position Summary: Responsible for collecting and processing blood samples from subjects as well as supporting the screening of subjects and ongoing compliance checks, collection of test specimens from subjects, assisting Nursing staff in obtaining Vital Signs, Height/Weight, Body Mass Index (BMI) and ECG data, and other activities in support of subject monitoring. Activities will also include processing of blood samples in a laboratory setting and assistance with preparing them for shipment. In addition, will serve meals and assist in keeping the Clinic clean. These activities require that the CRT read, understand, and train to the study protocol provided.   Duties and Responsibilities:
    • 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
      Qualifications:
    • CPR & First Aid certification preferred
    • Phlebotomy certification preferred
    • Flexible hours depending on business requirements.
    • Rotating shifts and weekend requirements
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com