Toronto, Ontario – Study Preparation Associate

Reports to: Supervisor, Clinical Research

 

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:

  1. Responsible for the accurate and timely preparation of all study related documents, including the creation of study specific forms in paper and electronic format.
  2. 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.
  3. Responsible for the creation and maintenance of Sponsor requested source documents.
  4. Maintains accurate, complete, legible and timely records.
  5. Participates in the development of internal staff training programs.
  6. Assists with the maintenance of clinical related regulatory documents for the Regulatory Binder.
  7. Ensures the maintenance of Clinic/Administration fax, printer and photocopy equipment.
  8. Perform other tasks as assigned and as training and experience allow.

 

Qualifications:

  1. College diploma in science or business administration preferred but not required, or sufficient experience.
  2. Excellent computer skills (e.g. MS excel, word, etc)
  3. Excellent organizational skills with attention to details
  4. Proven track record of attendance.
  5. Flexibility in working hours as per business needs.
  6. Knowledge of ICH-GCPs and professional experience working in CRO preferred

 

Please send your resume to resumes@biopharmaservices.com