- posted in Careers
Reports to: Senior Manager, Medical Writing and Research
Duties and Responsibilities:
- Write Phase 1 and Bioequivalence Study Protocols, Informed Consent Forms, and Clinical Study Reports.
- Interact with Institutional Review Boards with respect to Protocols, Informed Consent Forms and other documents as required. Act as a secondary liaison between the company and the Institutional Review Board.
- Assist in the development of document templates, relevant Standard Operating Procedures (SOPs) and guidelines.
- Work closely with clinical personnel and the Principal Investigator to ensure that clinical documents are produced to the standard required by Good Clinical Practice (GCP).
- Ensure accurate and complete documentation of all clinic study source documents and/or forms according to company’s SOP, GCP and other applicable guidelines.
- Conduct all work in compliance with SOP’s, GCP and to observe all regulatory guidelines.
- Compile study documents.
- Clinical data entry and Quality Control when required.
- Photocopy and scan study documents.
- Perform other work as assigned
- Minimum university degree, B.Sc. (i.e. Life Sciences) or at least 4 years of pharmaceutical and/or clinical experience.
- Experience in an CRO environment, preferably in the conduct of Phase I and Bioequivalence studies
- Good interpersonal and communication skills.
- Attentive to details, good initiative and able to work with changing priorities
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