Clinical Trials

Seven Consultancy

1 - 5 years

4 - 8 Lacs

chennai tamil nadu india

Posted:4 days ago| Platform: Foundit logo

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Skills Required

medical writing pharmaceutical pharmacy clinical data management medicine clinical trials

Work Mode

On-site

Job Type

Full Time

Job Description

Creating and writing trial protocols and presenting them to the steering committee.
Identifying, evaluating, and establishing trial sites, and closing sites after trial completion.
Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
Liaising with ethics committees regarding the rights, safety, and well-being of trial subjects.
Ordering, tracking, and managing investigational products (IP) and trial materials.
Overseeing and documenting IP dispensing, inventory, and reconciliation.
Protecting subject confidentiality, updating their information, and verifying IP administration according to protocol.
Conducting regular site visits, coordinating project meetings, and preparing visit reports.
Implementing corrective action plans for underperforming sites.
Liaising with regulatory authorities as required.
Ensuring compliance with SOPs, local regulations, ICH, and GCP guidelines.
Performing other clinical research tasks and responsibilities as assigned.

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