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:
- Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
- Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
- Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment, and enrolment, CRF completion and submission, and data query generation and resolution
- Provide project updates to project management team.
- Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.
- Perform investigational product inventory, ensuring return of unused investigational product to designated location or verifies destruction as required.
- Assists with, and attends, Investigator Meetings for assigned studies.
- Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate Issues at site to project management.
- Collect and review essential study documents from site for filing in eTMF.
- Administer protocol and study related training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate quality and integrity of study site practices related to the proper study conduct, ensuring adherence to applicable regulations.
- Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
- To lead and partake in regular team meeting / teleconferences.
- Assist, as appropriate, with reporting site performance regarding timelines and deliverables to the project team during team meetings and assist with providing feedback for analysis of overall study performance.
- Other duties as assigned.
Your Profile:
- Bachelor’s Degree in biomedical sciences or related scientific discipline
- Fluent English (oral and written) and applicable local business language.
- Minimum one-year monitoring experience, more experience would be preferred, along with combination of clinical research coordinator and or other relevant clinical research experience.
- Sound knowledge of medical terminologies and clinical monitoring process.
- Sound knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
- Excellent verbal, written communication, and presentation skills.
- Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint, and Excel).
- Effective business skills for interactive situations with peers, sites, and clients.
- Location: Mumbai, India.
If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.