Phlebotomists Group Leader

2 months ago

Toronto, Canada Pharma Medica Research Inc. Full time

Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are always looking for top talent to join our growing team  We're currently looking for a Group Leader to join our phlebotomists team

The Group Leader, MLA supervises and/or perform all aspects of the study procedures and ensure proper documentation of clinical activities are in compliance with Pharma Medica Research Inc (PMRI) SOP, GCP guidelines, FDA/TPP regulations. This position reports to Manager, Group Leaders and/or designate.

Duties and Responsibilities

Responsibilities include but are not limited to:

1.Supervise and oversee the on-floor clinic activities and ensure all assigned clinic staff members perform tasks as per SOPs and protocols and document data in compliance with GCP.

2.Perform all aspects of the study procedures and ensure proper documentation of clinical activities that are in compliance with SOP, GCP guidelines, FDA/TPP regulations.

3.Assist and/or manage subjects' concerns or conflicts between staff and/or subjects.

4.Ensure management and the Study Coordinator is kept up to date regarding all major clinic deviations, issues, and subject conflicts.

5.Assist in hiring new Medical Laboratory Assistants (MLAs).

6.Responsible for training new MLAs and coaching existing MLAs on a daily basis.

7.Responsible for training and updating MLAs on new and revised clinic procedures.

8.Ensure training records for MLAs are updated.

9.Responsible for delegation of clinic duties to all MLAs.

10.Assist Study Coordinators in updating all MLAs regarding the status of the study.

11.Ensure that the ICF is provided to the subjects, answer any questions the subjects may have regarding the protocol and informed consent, and sign the Informed Consent Forms.

12.Perform safety-related procedures as required (e.g., vital signs, electrocardiograms, concomitant medication administration, recording adverse events, etc.) and health monitoring.

13.Ensure the clinic is prepared for a clinical study (i.e. tube labelling, bunk room preparation, set up bleeding stations, etc.).

14.Prepare clinic supplies, bunk beds and seat assignments for each study.

15.Ensure general cleaning duties are performed (i.e., decontaminate workstations and equipment such as centrifuges).

16.Ensure sufficient supplies are present in the clinic for upcoming studies.

17.Assist in reviewing study documentation.

18.Assist with responses to QA/QC findings and subject follow-up.

19.Assist in the performance evaluation of MLAs.

20.Handle medical emergency situations with Study Nurses and Study Coordinators.

21.Participate regularly in all PMRI training programs including SOP, GCP training, and PMRI in-house training modules.

22.Achieve 80% or greater in all PMRI training evaluations including GCP, SOP tests and PMRI in-house training module tests.

23.Follow Joint Health and Safety rules and regulations at all times.

24.Other duties as required.

Qualifications:

  • B.Sc. degree or equivalent.
  • Completion of a recognized Phlebotomy/ECG program recommended.
  • OSMT certification.
  • Benchtop laboratory work experience is an asset.
  • Knowledge of GCP.
  • First aid and CPR certification 
  • 2-5 years CRO experience or equivalent.
  • Previous MLA Group Leader designation.
  • Supervisory and training experience in related industry.
  • Excellent verbal and written English communication skills.
  • Excellent interpersonal and organizational skills.
  • Ability to work both independently and as a team member.
  • Excellent computer skills and proficient in Microsoft Office.

We Offer

  • Competitive compensation plan
  • Opportunities for advancement and career progression
  • A generous Employee Milestones Awards Program
  • Corporate Discounts Program
  • Learning Support Programs
  • Friendly atmosphere, culture of learning

Please note all applications must be eligible to work within Canada.

PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.

We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.

If you meet the qualifications and are looking for an exciting place to work, apply today

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