Biorasi, an award-winning, customer-focused, full-service clinical research organization, is seeking a Clinical Project Associate to join our dynamic and innovative team in Mumbai, India. We are looking for individuals who are passionate about clinical research and eager to make a meaningful impact in the expanding clinical research industry.
Key Responsibilities:
- Communication: Participate in meetings/teleconferences, develop and distribute meeting agendas, minutes, monthly status reports, and track action items to document key project updates.
- Site Management: Assist with site budget development, contracts, and payment administration. Support Clinical Trial Managers in tracking subject recruitment, Monitoring Visits, protocol deviations, and communication with study sites.
- Study Start-up: Support project managers in the development of plans and documents required for site feasibility, selection, and activation.
- Site Activation: Coordinate retrieval and review of regulatory documents required for the initiation of clinical trials.
- Document Management: Assist in the collection, review, filing, and archival of essential documents, maintaining the Trial Master File.
- Supplies Management: Coordinate logistics, track clinical supplies, and manage the distribution and collection of study materials.
- Study Management: Assist in creating and maintaining project trackers and relevant systems, routine correspondence, and distribution to relevant stakeholders.
- Vendor Management: Assist with vendor identification, qualification, selection, and management throughout a clinical trial.
- Compliance: Follow ICH GCP guidelines and SOPs, assist in audit readiness, and participate in client presentations and Investigator Meetings.
- Other Duties: Assist in ensuring timelines are met and communicate any out-of-scope issues to upper management.
Your Profile:
- Fluent in English (oral and written) and applicable local business language.
- Clinical research experience is required; prior experience as a study coordinator and/or regulatory coordinator is preferred.
- Basic knowledge of ICH GCP and applicable local regulatory requirements.
- Proficiency with MS Office suite (Word, PowerPoint, Excel).
Benefits:
- Half-day Fridays, paid time off, and paid holidays.
- Extensive country-specific benefits and employee bonus programs.
- Career growth opportunities, training, and development.
