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OUR CURRENT CAREER OPPORTUNITIES

Want to be inspired?

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 - Clinical Research Recruiter

Position Summary:

Perform telephone interview and day-to-day activities of Recruiting department.

Duties and Responsibilities:

  • Conduct telephone eligibility screening of potential English-speaking volunteers for inclusion or exclusion in all phases of clinical trials which includes but is not limited to, Reviewing screening criteria, Providing an overview of the study,Responding to volunteer preliminary questions, Capturing brief medical and medication history of volunteers, Completion of required paperwork
  • Book appointments for potential volunteers for onsite screening and assign volunteers to studies based on the results of medical screening visits
  • Daily data entry, maintenance and updating of electronic volunteer files into Bio Pharma Services Inc. subject database for telephone recruitment
  • Track statistics for clinical trials including but not limited to fill ratio, advertisement responses, and volunteer no show rates
  • Create documents as required by recruitment and screening processes including, but not limited to, Create Recruitment packages, Prepare lists for screening, Process referrals and referral payments, Master lists for Check-ins
  • Participate in training of new hires if experience allows
  • Involvement in departmental meetings
  • Cooperate with and support the Quality Assurance (QA) group during audit activities
  • Ensure compliance with appropriate BioPharma Services Inc. SOP’s and GCP and ICH guidelines
  • Other duties as may be required & as training and experience allow
  • Qualifications:
    • 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
    • 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
    • Proficient 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

    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 the development of SAS codes 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 as a Lead 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:
       
    • B.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 - Project Manager

    REPORTS TO:
      Manager, Project Management

      POSITION SUMMARY:

      To oversee all associated activities related to a Phase I/BE study program from inception (i.e. Study award) to completion (i.e. issuance of final report). Maintain awareness of overall study requirements in accordance with finalized protocol and ensure this is adhered to in all projects managed under your responsibility.

      GENERAL RESPONSIBILITIES:

    • Maintain a tracking process for the studies managed; including initiation, tracking, timelines reporting, budgeting and report writing
    • Within scope of position, provide sound scientific advice to clients either directly or via other BPSI staff; co-ordinate teleconferences with appropriate personnel, address client questions, concerns or comments
    • Negotiate client’s milestones and assist staff as required
    • Use appropriate communication tools to update clients on the status of their project(s); should there be any deviation, immediately handle them appropriately and if required notify Manager, Project Management and/or Operations
    • Actively participate in the weekly tracking meeting making sure you are current with the most current information from operations and provide any new client information
    • Follow up with existing accounts on new business opportunities and manage activities around outstanding quotations, Confidentiality Agreements, contracts etc.
    • Whenever appropriate, maintain awareness and provide input on study designs and protocols
    • Assist in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion (includes quotation and contract templates, weekly tracking reports, financial reports etc.)
    • Ensure appropriate documents have been reviewed and circulated within BPSI prior to providing to clients
    • Maintain a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA, ICH, TGA, ANVISA) and understanding of basic pharmacokinetics and statistics
    • Assist finance department in developing transfer of pertinent financial information

    • QUALIFICATIONS:
    • Bachelor of Science (B.Sc.) degree or equivalent
    • Relevant background in the healthcare, pharmaceutical industry
    • Minimum of 2 years experience in a project management role in either Phase I/BE or Phase I - IV setting
    • Familiarity with the management of all phase I/BE
    • Demonstrated experience dealing with a wide variety of project stakeholders at all levels in and across various organizational departments
    • Excellent interpersonal, communication and presentation skills
    • Strong organization, prioritization and problem solving skills
    • Ability to manage and handle several projects simultaneously
    • Highly proficient in MS Office Suite (Word, Excel, PowerPoint, MS Project)
    Please send your application to Igor Grahovac - Manager, Project Management: igrahovac@biopharmaservices.com

    Toronto, Ontario - Senior Project Manager

    Position Summary:
    • To oversee all associated activities related to a Phase I/BE study program from inception (i.e. Study award) to completion (i.e. issuance of final report).  Maintain awareness of overall study requirements in accordance with finalized protocol and ensure this is adhered to in all projects managed under your responsibility.
    • Duties and Responsibilities:
      • Maintain a tracking process for the studies managed; including initiation, tracking, timelines reporting, budgeting and report writing
      • Within scope of position, provide sound scientific advice to clients either directly or via other BPSI staff; co-ordinate teleconferences with appropriate personnel, address client questions, concerns or comments
      • Serve as key client contact for assigned projects, establishing working relationship with client’s project team which result in client satisfaction, operational excellence and potential repeat business
      • Act as escalation point for project issues to internal and external stakeholders
      • Use appropriate communication tools to update clients on the status of their project(s); should there be any deviation, immediately handle them appropriately and if required notify Manager, Project Management and/or Operations Management
      • Monitor project scope, schedule and costs to ensure all are on track as per agreement and with financial performance targets.
      • Lead core project team and facilitate team’s ability to lead extended project teams ensuring effective cross-functional teamwork among project team members
      • Actively participate in the weekly tracking meeting making to ensure timelines are current with the most up-to date information from operations and provide any new information available from the client
      • Follow up with existing accounts on new business opportunities and manage activities around outstanding proposals and contracts
      • Assist in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion (includes quotation and contract templates, weekly tracking reports, financial reports etc.)
      • Ensure appropriate documents have been reviewed and circulated within BPSI prior to providing to clients
      • If required, assist in promotion of BPSI at industry meetings and trade shows
      • Maintain a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA, ICH, TGA, ANVISA) and understanding of basic pharmacokinetics and statistics
      • Assist finance department in developing transfer of pertinent financial information
      • Coordinate client visits and follow up on requested documents from clients including, but not limited to, regulatory documents, study documents, validation report and brochures
      • Perform other tasks and projects as assigned
      • Qualifications:
        • Bachelor of Science (B.Sc.) degree or equivalent
        • Relevant background in the healthcare, pharmaceutical industry
        • Minimum of 3 years’ experience in a senior project management role in either Phase I/BE or Phase I - IV setting
        • Experience in managing all trial components (study initiation to final CSR)
        • Demonstrated experience dealing with a wide variety of project stakeholders at all levels in and across various organizational departments
        • Working knowledge of ICH Guidelines and GCP including international requirements for the conduct of clinical trials
        • Working knowledge of project management processes
        • Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
        • Excellent interpersonal, communication and presentation skills
        • Strong organization, prioritization and problem solving skills
        • Ability to negotiate and liaise with clients in a professional manner
        • Highly proficient in MS Office Suite (Word, Excel, PowerPoint, MS Project)
        Please send your application to Igor Grahovac - Manager, Project Management: igrahovac@biopharmaservices.com

    Toronto, Ontario – Senior 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
  • Preparation of Study Master List, and conducting stand-by lottery at study check-ins
  • Generate recruitment highlights (protocol summary)
  • Informing potential subjects of their medical screening results
  • Assigning tentative subject numbers
  • 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).
  • 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:
  • 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
  • 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-pace 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

  • 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

    no later than September 30th, 2019

    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

    Columbia, Missouri - Group Leader/Registered Nurse

    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.
    The Registered Nurse is responsible for monitoring subject safety while they are in confinement and in compliance with the study protocols, SOP’s, and regulatory requirements.


    Duties and Responsibilities:


    • Oversee 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
    • Complete compliance check on subjects as appropriate
    • Adverse Event Reporting and Serious Adverse Event reporting
    • 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
    • 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
    • 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).
    • Proper collecting, handling and processing of PK samples
    • Monitor and maintenance of Crash Cart
    • Cardiac Monitoring (Telemetry)
    • 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 other tasks/duties as assigned

      • Qualifications:


        • Registered Nurse with current registration with regulatory body in Missouri.
        • Current BCLS/ ACLS & First Aid certification.
        • At least 2 years’ experience in clinical research or relevant field is preferred
        • Relevant previous supervisory and/or training experience is required
        • Knowledge of Good Clinical Practice is preferred
        • Good interpersonal, communication, problem solving, organizational and leadership skills
        • Computer literacy: Microsoft Office.
        • Attentive to detail and able to work with changing priorities.
        • Ability to accommodate a flexible work schedule

        Please send your application to resumes@biopharmaservices.com

    Columbia, Missouri - Group Leader/Paramedic

    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.
    The Paramedic is responsible for monitoring subject safety while they are in confinement and in compliance with the study protocols, SOP’s, and regulatory requirements.


    Duties and Responsibilities:


    • Oversee 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
    • Complete compliance check on subjects as appropriate
    • Adverse Event Reporting and Serious Adverse Event reporting
    • 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
    • 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
    • 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).
    • Proper collecting, handling and processing of PK samples
    • Monitor and maintenance of Crash CarvCardiac Monitoring (Telemetry)
    • 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 other tasks/duties as assigned

      • Qualifications:


        • Paramedic with current registration with regulatory body in Missouri.
        • Current BLS and ACLS certifications
        • At least 2 years’ experience in clinical research or relevant field is preferred
        • Relevant previous supervisory and/or training experience is required
        • Knowledge of Good Clinical Practice is preferred
        • Good interpersonal, communication, problem solving, organizational and leadership skills
        • Computer literacy: Microsoft Office.
        • Attentive to detail and able to work with changing priorities.
        • Ability to accommodate a flexible work schedule

        Please send your application to resumes@biopharmaservices.com

    Columbia, Missouri - Licensed Practical Nurse (PT various shift, PPT evening/overnight shift)

    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
    • 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 (IV Certified LPN’s only)
    • Perform drug/cotinine screen and alcohol test
    • Proper collecting, handling and processing of PK samples
    • Monitor and maintenance of Crash Cart
    • Cardiac Monitoring (Telemetry) (Registered 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 Management
    Qualifications:
    • Licensed Practical 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/CPR certification preferred.
    • 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

    Columbia, Missouri - Clinical Research Technician (Evening/Overnight) BPS USA

    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 (with the exception of blood collection), 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 (if IATA certified)
    • 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 Management
      Qualifications:
    • CRO experience a plus
    • CPR & First Aid certification a plus
    • Phlebotomy certification preferred
    • Flexible hours depending on business requirements.
    • Rotating shifts and weekend requirements
    Please send your application to resumes@biopharmaservices.com

    Columbia, 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.
    Please send your application to resumes@biopharmaservices.com

    Columbia, Missouri - Clinical Research Coordinator

    Duties and Responsibilities:

    Coordinating conduct of the assigned clinical trial. This includes but is not limited to:

  • Preparation of study related documentation
  • Review and 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 Phase I and 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

    • Qualifications:
      • Flexible hours depending on business requirements.
      • Rotating shifts and weekend requirements.
      • 1-2 years work experience (preferred) in a CRO with experience in conducting Phase I /Bioequivalence clinical trials.
      • Excellent problem solving, communication, multitasking and interpersonal skills
      • Excellent in Microsoft Word and Excel.

      Please send your application to resumes@biopharmaservices.com

    Columbia, Missouri - Phase 1 -Principal Investigator

    Position Summary: Principal Investigator will be responsible for promoting Good Clinical Practice (GCP) in the conduct of Phase 1 clinical investigations by ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of the data generated and directing the conduct of the clinical investigation according to government regulations and guidance documents.

    Duties and Responsibilities:
    • Provides Investigator Qualifications and agreements
      • Maintaining a current, up-to-date curriculum vitae
      • Maintaining a current license to practice
      • Demonstrating proper education, training and experience to conduct a clinical investigation
      • Assuming responsibility for the conduct of the clinical investigation
      • Signing all required regulatory documents
      • Disclosing financial disclosure/interest as described by regulations
    • Ensuring Protocol Compliance
      • Possessing a thorough understanding of the requirements of each protocol
      • Determining that the inclusion/exclusion criteria are applicable to the study population
      • Following the trial’s randomization procedures
    • Ensures Initial and Ongoing Review by an IRB
      • Providing the IRB with adequate information to initially review the study
      • Providing the IRB with documents for ongoing review (e.g., protocol amendments, adverse events)
      • Securing written IRB approval prior to initiating a study or instituting any changes to the protocol as approved
    • Determines adequate resources are available to conduct the study
      • Having adequate number of qualified staff to conduct the study
      • Having adequate facilities to conduct the study
      • Ensuring adequate time to conduct and supervise the study
    • Manages the medical care of subjects
      • Responsible for all trial-related medical decisions
      • Assessing subject compliance with the test article and follow-up visits, Evaluating medical history, lab results, vital signs and ECGs
      • Conducting physical examinations
      • Evaluating adverse events
      • Ensuring that medical care is provided to a subject for any adverse event(s)
    • Informing a subject when medical care is needed to treat an intercurrent
    • illness(s)
    • Protects the rights and welfare of subjects
      • Reporting all serious adverse events immediately to the sponsor and IRB
      • Ensuring that the informed consent form contains all the elements required by GCP
      • Obtaining a signed and dated informed consent from each subject prior to initiating any study-related procedures
    • Informing the subject or legal representative about all aspects of the Clinical trial
    • Providing new information about the study
    • Ensures validity of the data reported to the sponsor
      • Ensuring the accuracy, completeness, legibility and timeliness of case report forms
      • Explaining any discrepancies or corrections on case report forms
    • Ensures documentation of study-related procedures, processes and events
      • Documenting deviations from the approved protocol
      • Documenting and explaining premature unblinding of the investigational product
    • Documenting that informed consent has been obtained from the subject
    • Ascertaining the reason for a patient’s premature study withdrawal
    • Documenting adverse events
    • Providing study reports as requested by the sponsor, IRB and regulatory authorities
    • Ensures the proper use and storage of investigational products
      • Being thoroughly familiar with the use of the investigational product(s)
      • Reading the current investigator’s brochure, product insert or other source information
      • Assuming responsibility for the investigational product at the trial site
      • Ensuring the proper use and storage of the investigational product(s) at the trial site
      • Reviewing the proper use of the study articles by the subjects
    • Direct Site Operations
      • Delegating authority and maintaining a delegation of authority list
      • Making available to monitors, auditors, IRB and regulatory authorities all requested trial-related records
      • Ensuring that all staff are informed about their trial related duties and functions
      Qualifications:
    • Current license with no restrictions
    • Current ACLS certification is preferred
    • Current DEA license
    • Able to work in a research setting and aware of the confidentiality that is required in research
    • Experience in Emergency Medicine, Clinical Research or related field an asset
    • Good communication skills, problem solving, organizational and leadership skills
    Please send your application to resumes@biopharmaservices.com

    Columbia, Missouri - Registered Nurse (Permanent Part-Time Evening Shift)

    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
    • 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
      Qualifications:
    • 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 (able to work other shift when needed)
      Please send your application to resumes@biopharmaservices.com

    Columbia, Missouri - PRN Paramedic (Permanent Part-Time Evening Shift)

    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 (able to work other shift when needed)
      Please send your application to resumes@biopharmaservices.com

    Columbia, 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
      Please send your application to resumes@biopharmaservices.com

    Columbia, Missouri – 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 (with the exception of blood collection), 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 (if IATA certified)
    • 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 Management

    Qualifications:

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

    Please send your resume to resumes@biopharmaservices.com