1. Graduate / Post Graduates in Life Sciences/ Pharmacy from a reputed institute
2. Prior knowledge of conduct of Clinical Trials,
3. Phases of Clinical trials and
4. Thorough Knowledge of ICH-GCP and other regulatory guidelines.
Roles and Responsibilities:
1. Prepare the Database of the Investigators at the place assigned to you.
2. Interact with the Investigators and know about their interest in working with us.
3. Get the feasibilities completed by the Investigators in the given time.
4. Collect all the necessary documents.
5. Compiles, tracks, and archives study documents, such as subject enrollment logs, serious adverse event (SAE) reports, IND, and Safety Reports, etc.
6. Coordinates, organizes, and sets up meeting agendas, and communicates pertinent information, as required.
7. Documents, compiles data, and distributes the notated minutes from Departmental and Project Team Meetings, as required.
8. Inventories, coordinates, and tracks timely shipments of clinical study center supplies and drugs to investigational sites, as needed.
9. Sorts, runs, and submits requested periodic reports from computer database, as required.
10. Assists and contributes to individual development and training, knowledge, and expertise through research, technical bulletins, and attending appropriate seminars.
11. Develops and edits PowerPoint multi-media presentations.
12. Organizes and supports teleconferences/videoconferences and internal/external meetings, including coordinates/reserves conference logistics, audiovisual equipment, food arrangements, etc.
13. Drafts, edits, and processes correspondence, reports, memos, forms, etc.
14. Maintains site master file, source documents and other site related activities.
15. Should report principal investigator at site everyday for day to day activities.
16. Adapts to various situations and adjusts to shifting priorities.
17. Performs other duties as assigned.