Study Planning Specialist

1 day ago

London, Ontario, Canada Pharma Medica Research Inc. Full time

About Us

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Pharma Medica Research Inc. is a full-service contract research organization (CRO) that specializes in conducting early phase clinical trials in various settings, including healthy volunteers, special populations, and patients.

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We are seeking a skilled Study Planning Specialist to join our team at our Scarborough clinic location.

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Job Overview

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The Study Coordinator will oversee the planning and execution of clinical studies, ensuring adherence to protocols, SOPs, and GCP guidelines. This role requires strong leadership and coordination skills to manage technical staff, monitor adverse events, and collaborate with other departments.

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Key Responsibilities:

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  1. \
  2. Ensure the availability of necessary study materials, including the final protocol, signed regulatory documents, and NOLs, prior to study commencement.\
  3. Prepare and distribute study-specific staff schedules to ensure efficient study execution.\
  4. Coordinate with the Pharmacy department to secure study drugs and arrange pre-study protocol review meetings for technical teams.\
  5. Supervise and/or perform all technical functions, including phlebotomy, ECG, vital signs, and other clinical tasks, to generate data in compliance with protocol, SOP, and GCP.\
  6. Monitor and document adverse events and facilitate timely subject compensation through collaboration with the Accounting department.\
  7. Generate client updates and submit study files to QA and Report Writers as required.\
  8. Resolve conflicts among subjects and address their concerns in a professional manner.\
  9. Respond to queries and findings from QC units and QA.\
  10. Perform additional duties as assigned by management.\
    1. \

Requirements

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  • A minimum B.Sc. degree or relevant experience in a Phase I clinic setting.\
  • 1 year of experience in a Phase I clinic setting or 2 years of related experience within a Phase I clinical center.\
  • Clinical Research Coordinator certification as per ACRP guidelines.\
  • Strong understanding of Phase I study protocols and conduct.\
  • Familiarity with training and SOPs related to study conduct.\
  • GCP training.\
  • Proficiency in computer software and excellent communication skills.\
  • Ability to work independently and collaboratively as part of a team.\
  • Exceptional organizational and time management skills.\
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About Our Team

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At Pharma Medica Research Inc., we pride ourselves on being a dynamic and supportive team dedicated to advancing medical knowledge and improving human health. We invite you to join our team of experts and contribute your skills and experience to help us achieve our goals.

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