Lead Clinical Research Associate
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Job Description
Lead CRA overseeing regional clinical trial quality for PSI CRO, a global contract research organization. Mentoring monitors and coordinating compliance, data integrity, and study operations remotely.
Responsibilities:
- Provide leadership, oversight, and mentorship across regional clinical trials
- Partner with Project Managers, Regional Project Leads, CRAs, and cross-functional teams to ensure high-quality study execution
- Monitor project timelines, patient enrollment, data cleaning, and compliance; implement corrective and preventive measures
- Review monitoring visit reports and ensure regional reporting compliance
- Serve as the main communication line between Monitors, Site Management Associates, Regional Project Leads, and Project Managers
- Lead country-level project team calls and provide status updates and reports
- Lead project-specific training and prepare training materials
- Supervise source data verification, follow up on data queries, and manage site-level study risks
- Ensure proper handling, accountability, reconciliation, and return of investigational products and clinical study supplies
- Review essential study documents and supervise reconciliation of ISF/TMF files
- Ensure site-level data integrity and compliance
- Collaborate on investigator/site feasibility, identification, and study startup
- Manage Monitors in query resolution, including central monitoring observations
- Coordinate safety information flow and protocol/process deviation reporting
- Manage clinical supplies with vendors at country and regional levels
- Maintain study-specific and corporate tracking systems
- Coordinate and conduct supervised monitoring visits
- Manage site contracting and payments
- Evaluate data integrity and compliance at country/regional level
- Prepare for and participate in site audits and coordinate resolution of audit findings
- Oversee CAPA development and implementation
- Coordinate process deviation review, management, and reporting
- Conduct initial training and authorization monitoring visits for Monitors; mentor newly promoted Lead CRAs
- Deliver trainings and presentations at Investigator Meetings
- Ensure subject recruitment targets and timelines are defined, communicated, recorded, and met
- Ensure timely information flow with trial sites on adverse events and protocol/process deviations
- Supervise Site Management Associates in document and laboratory supply flows
- Support preparation of regulatory and ethics committee submission packages
Requirements:
- Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience
- Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level
- Experience with all types of monitoring visits in Phase II and/or III
- Strong experience in Oncology preferred
- Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, or Nuclear Medicine preferred
- Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Excellent Communication, collaboration, and problem-solving skills
- Ability to travel
- Valid driver’s license (if applicable)
- PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future
Benefits:
- A stable, privately held CRO that has never undergone a merger or acquisition and has never experienced company-wide layoffs
- A unique leadership-focused CRA role with minimal travel and little to no routine site assignments
- Opportunities to mentor other CRAs and expand your leadership skills
- A collaborative, people-first culture where employees are genuinely supported
- Career development opportunities across a growing global organization
- The chance to contribute to innovative clinical research that improves patients' lives
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