Clinical Research Associate Lead

4 weeks ago

Bengaluru, Karnataka, India PSI CRO Full time
Job Title: Lead Clinical Research Associate

Job Summary:

We are seeking a highly skilled and experienced Lead Clinical Research Associate to join our team at PSI CRO. The successful candidate will be responsible for leading clinical research projects, ensuring timely and efficient execution, and providing guidance to junior team members.

Key Responsibilities:
  • Lead clinical research projects from start to finish, ensuring compliance with regulatory requirements and company standards.
  • Supervise and mentor junior team members, providing guidance and support to ensure successful project execution.
  • 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.
  • Coordinate investigator/site feasibility and identification processes, ensuring timely and efficient site selection.
  • Review and manage IP-RED/site regulatory packages, ensuring compliance with regulatory requirements.
  • 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 and efficient supply chain management.
  • Ensure study-specific and corporate tracking systems are updated in a timely manner.
  • Conduct supervised monitoring visits in the projects, providing guidance and support to junior team members.
  • Provide project-specific training to project teams and prepare training materials for the project teams.
  • Manage the project team in site contracting and payments, ensuring timely and efficient financial management.
  • Lead project team calls on a country level, providing guidance and support to junior team members.
  • Provide status updates and reports to Regional Lead/Project Manager, ensuring timely and efficient communication.
  • Deliver trainings and presentations at Investigator Meetings, conduct project-specific trainings of Investigators.
  • Supervise Site Management Associates in maintaining tracking systems, document and laboratory supplies flow.
  • Conduct site audit preparation visits, may participate in site audits, and coordinate resolution of site audit findings.
Qualifications:
  • College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & 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 be able 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.
Additional Information:

At PSI CRO, we are committed to investing in our people and their professional development and success. We offer a dynamic and supportive work environment, opportunities for growth and advancement, and a competitive compensation package. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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