Responsibilities as Project coordinator:
- Responsible for planning, management, controlling and documentation of the studies
- To assist in the preparation of draft protocols with Clinical Development department and planning of studies.
- Co-ordinate related documents like informed consent documents, study design, CRF etc.
- Coordinate between sponsor’s representative to finalize the protocol, obtain investigational products and other relevant correspondences.
- Coordinate between Principal Investigator and IEC for protocol review and appropriate approvals.
- Coordinate with central laboratory for project management and execution.
- Arrange laboratory logistics for the smooth conduct of screening activities for a study.
- To manage logistics for the conduct of the study.
- Compile all the relevant data pertaining to the study and file the same.
- Assist medical writing team, clinical investigator and Principal Investigator to prepare study report.
- Responsible for obtaining & maintenance of study related documents.
- To coordinate with the quality control & quality assurance department for the smooth conduct of the clinical study and to provide all relevant documents for QC Check/QA Audits.
- To cooperate and assist with quality assurance department for external sponsor audits and other regulatory inspection.
- To carry out other responsibilities that may be assigned by Principal Investigator, Head-Human Pharmacology Unit/Head of Syngene Clinical Development Team.
Educational Qualification: BPharma, MSc
Technical/functional Skills:
- Ability to communicate with clients.
- Sound knowledge about clinical research.
- MS office skills.
Experience: 0-3 years
Behavioral Skills:
- Good communication,
- Quick learner,
- Adapt to changes,
- Time management,
- Professionalism.
- Effective Planning and Organizing skills.
- Good Business/Industry Awareness.
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