Clinical Research Associate Lead
4 weeks ago
At PSI CRO, we are seeking a highly skilled and experienced Lead Clinical Research Associate to join our team.
Job Summary:The Lead Clinical Research Associate will be responsible for overseeing the clinical research projects, ensuring timely completion, and maintaining high-quality standards. This role will involve supervising study startup and site monitoring, coordinating investigator/site feasibility and identification, and managing clinical supplies.
Key Responsibilities:- Monitor project timelines and patient enrollment, implementing corrective and preventive measures as needed.
- Act as the primary point of contact between the Sponsor, Project Manager, and sites for protocol-related updates.
- Conduct clinical site monitoring and management activities, ensuring compliance with regulatory requirements.
- Coordinate investigator/site feasibility and identification processes, ensuring timely site selection.
- Manage clinical supplies, ensuring timely delivery and inventory management.
- Review IP-RED/site regulatory packages, ensuring compliance with regulatory requirements.
- Review monitoring visit reports, ensuring reporting compliance of CRAs.
- Manage CRAs in the query resolution process, including Central Monitoring observations.
- Coordinate safety information flow and protocol/process deviation reporting.
- Perform clinical supplies management with vendors, ensuring timely delivery and inventory management.
- Ensure study-specific and corporate tracking systems are updated in a timely manner.
- Conduct supervised monitoring visits in the projects, ensuring high-quality standards.
- Provide project-specific training to project teams, preparing training materials as needed.
- Manage the project team in site contracting and payments, ensuring timely and accurate processing.
- Lead project team calls on a country level, ensuring effective communication and collaboration.
- Provide status updates and reports to Regional Lead/Project Manager, ensuring timely and accurate reporting.
- Deliver trainings and presentations at Investigator Meetings, conducting project-specific trainings as needed.
- Supervise Site Management Associates in maintaining tracking systems, document, and laboratory supplies flow.
- Conduct site audit preparation visits, participating in site audits as needed, and coordinating resolution of site audit findings.
- College/University degree in Life Sciences, Pharmacy, RN, or an equivalent combination of education, training, and experience.
- Participation in clinical projects as a Lead/Senior Monitor.
- Independent on-site monitoring experience in India.
- Full working proficiency in English.
- PC skills to work with MS Word, Excel, and PowerPoint.
- Ability to plan, multitask, and work in a dynamic team environment.
- Communication, leadership, and problem-solving skills.
- Ability to travel.
At PSI CRO, we prioritize our people and invest in their professional development and success. If you are a motivated and experienced professional looking to take your career to the next level, we encourage you to apply for this exciting opportunity.
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