Are you passionate about clinical research and eager to play a key role in driving new therapies to patients? Biorasi, an award-winning, customer-focused full-service clinical research organization (CRO), is looking for a Clinical Project Associate in Mumbai, Maharashtra, India. This position is ideal for individuals who are excited to contribute to a dynamic and evolving company that encourages innovation and work-life balance.
About Biorasi
Biorasi is a rapidly growing global company in the clinical research industry, dedicated to delivering cutting-edge therapies to patients. The company prides itself on its collaborative, innovative, and dynamic work environment, fostering both personal and professional growth for its employees.
Key Responsibilities of the Clinical Project Associate
As a Clinical Project Associate, you will be responsible for:
- Communication: Participating in meetings/teleconferences, preparing agendas, minutes, and monthly status reports. You will also document and distribute key project updates to relevant stakeholders.
- Site Management: Assisting in developing site budgets, managing contracts, and administering payments for clinical trial sites.
- Clinical Trial Tracking: Supporting Clinical Trial Managers in tracking subject recruitment, monitoring visits, and protocol deviations across all study sites.
- Study Start-Up: Assisting in the development of project plans and documents necessary for site feasibility, selection, and activation.
- Site Activation: Coordinating with the project team to retrieve and review regulatory documents essential for clinical trial initiation.
- Document Management: Collecting, reviewing, filing, and archiving essential documents while maintaining the Trial Master File (TMF).
- Supplies Management: Managing logistics, including study materials, supplies, and tracking at the site level in coordination with established study systems.
- Study Management: Helping create and maintain project trackers and relevant systems (e.g., CTMS, study portal) and distributing communications to project teams, sponsors, sites, and other stakeholders.
- Vendor Management: Assisting with vendor identification, qualification, selection, and management during the clinical trial, including vendor payment administration.
- Compliance: Following international GCP guidelines, local regulations, and SOPs while assisting the project team with audit findings and documentation for audit readiness.
- Meetings Participation: Participating in client presentations and Investigator Meetings as necessary.
- Out-of-Scope Issues: Communicating any out-of-scope issues to upper management and assisting study teams in meeting timelines.
