Job Description
Prepare project plan as per the project timelines, budget and deliverables & Complete the assigned project in Qualitative, cost effective and time bound manner.
Develop the contract and budget for clinical trial projects.
Conduct feasibility studies.
Track timelines, milestones and budget requirements for assigned projects
Coordinate for the required regulatory submission and approvals for the conduct of the study and CTRI registration.
Allocate CTL’s/CRA’s to clinical trial projects.
Develop appropriate study tools and tracking system
Assist new CTL’s/CRA’s in identifying and developing investigators for assigned studies.
Assist in selection of the sites in conjunction with sponsor and lambda and recommend site assignments.
Provide protocol specific training to the CTL’s/CRA’s including therapeutic expertise, CRF conventions, study procedures and SOP’s
Conduct quality control and co-monitoring visits with CTL’s/CRA’s to ensure quality and compliance with SOP’s, GCP and project requirements.
Review and approve payments to the study site and vendors.
Prepare reports and updates for sponsor.
Ensure effective communication between stake holders and all project team members.