Creating and writing trial protocols, and presenting these to the steering committee.
Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
Ordering, tracking, and managing IP and trial materials.
Overseeing and documenting IP dispensing inventory, and reconciliation.
Protecting subjects confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
Conducting regular site visits, coordinating project meetings, and writing visit reports.
Implementing action plans for sites not meeting expectations.
Liaising with regulatory authorities.
Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
Other tasks and responsibilities as needed.
Employement Category:
Employement Type: Full time Industry: Medical / Healthcare Role Category: Medical TranscriptionPharmacist / Medical Representative Functional Area: Not Applicable Role/Responsibilies: Clinical Associate
Contact Details:
Company: Yashpal Singh 1 Hiring Location(s): Multi-City, India