Biorasi is hiring a Clinical Project Associate in Mumbai. This role involves supporting clinical trial management, ensuring compliance with regulations, and collaborating with cross-functional teams to meet project milestones. Candidates should have a background in life sciences, excellent communication skills, and experience in clinical research.

Clinical Project Associate

Mumbai, India

We are Growing! Let us support your career journey the Biorasi way.  Innovative, Collaborative, Dynamic and Evolving.  Capitalizing on your strengths while encouraging work-life balance.  Biorasi is an award-winning, customer-focused, full-service clinical research organization.

Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Your role:

• Communication: Partake in meetings/teleconferences. Develop and distribute meeting agendas, minutes, monthly status reports, and action item distribution and tracking to document key project updates and communications to relevant stakeholders, as requested.
• Site Management:  Assist with the development of sites budgets, contracts, and payments administration.
• Support Clinical Trial Managers in tracking subject recruitment at all study sites, track study Monitoring Visits, protocol deviations, reporting and trending. Assist in communication to sites.
• Study Start-up: Support Clinical Trial Managers and Project Managers in the development of project plans and documents required for site feasibility, selection, and activation.
• Site Activation: Coordinate with the project team in retrieval and review of regulatory documents required for initiation of a clinical trial.
• Document Management: assist project team in the collection, review, filing, and archival of essential documents, and maintenance of the Trial Master File.
• Supplies Management: Assist with the coordination of logistics of the project, including printing of study tools and materials, securing study supplies, helping with the distribution, tracking and collection of study supplies and materials.  Track clinical supplies at the site level in coordination with established study systems.
• Study Management: Assist project team members to create and maintain project trackers, relevant systems (e.g., CTMS, study portal) routine correspondence messages and distribute to project team, Sponsor, sites, and other stakeholders based on relevance.
• Vendor Management: Assist with the  vendor identification, qualification, selection, and management throughout a clinical trial, including administration of vendor payments.
• Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Assist the Project team in the resolution of audit findings; assist project team in review and maintenance of clinical trial documentation for audit readiness.
• Participate at client presentation meetings and Investigator Meetings (IM) as necessary.
• Communicate any out-of-scope issues to upper management as soon as identified.
• Assist the study teams in meeting timelines.
• Other duties as assigned.

Your Profile:

• Associates or Bachelor’s degree in biomedical sciences or related scientific discipline; or sufficient work experience in related field
• Fluent English (oral and written) and applicable local business language.
• Clinical research experience required.  Prior experience as a study coordinator and/or regulatory coordinator preferred.
• Desired basic knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements / Knowledge and understanding of ICH GCP and applicable local regulatory requirements.
• Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint, and Excel)