Clinical Research Associate Lead
7 days ago
At PSI CRO, we are seeking a highly skilled and experienced Lead Clinical Research Associate to join our team. As a Lead CRA, you will play a critical role in the success of our global clinical research projects.
Key Responsibilities:- Monitor project timelines and patient enrollment, implementing corrective and preventive measures as needed.
- Act as the main 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.
- Oversee study startup and ensure timely completion of site initiation visits.
- Review and approve IP-RED/site regulatory packages.
- Manage Central Monitoring observations and ensure reporting compliance of CRAs.
- Coordinate safety information flow and protocol/process deviation reporting.
- Perform clinical supplies management with vendors.
- Ensure study-specific and corporate tracking systems are updated in a timely manner.
- Conduct supervised monitoring visits and provide project-specific training to project teams.
- Manage project team in site contracting and payments.
- Lead project team calls on a country level and provide status updates to Regional Lead/Project Manager.
- Deliver trainings and presentations at Investigator Meetings and conduct project-specific trainings of Investigators.
- Supervise Site Management Associates in maintaining tracking systems, document, and laboratory supplies flow.
- Conduct site audit preparation visits and participate in site audits, 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. We offer a dynamic work environment, opportunities for growth, and a chance to make a meaningful impact in the clinical research industry.
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