Lead Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide leadership, oversight, and mentorship across regional clinical trials.

• Collaborate with Project Managers, Regional Project Leads, Clinical Research Associates (CRAs), and cross-functional teams to ensure the execution of high-quality studies.

• Monitor project timelines, patient enrollment, data cleaning, and compliance while implementing corrective and preventive measures as necessary.

• Review monitoring visit reports to ensure compliance with regional reporting standards.

• Act as the primary communication conduit between Monitors, Site Management Associates, Regional Project Leads, and Project Managers.

• Lead country-level project team meetings and provide status updates and reports.

• Conduct project-specific training sessions and prepare relevant training materials.

• Oversee source data verification, address data queries, and manage site-level study risks.

• Ensure the proper handling, accountability, reconciliation, and return of investigational products and clinical study supplies.

• Review essential study documents and supervise the reconciliation of Investigator Site Files (ISF) and Trial Master Files (TMF).

• Ensure data integrity and compliance at the site level.

• Collaborate on investigator/site feasibility assessments, identification, and study initiation.

• Manage Monitors in resolving queries, including addressing central monitoring observations.

• Coordinate the flow of safety information and reporting of protocol/process deviations.

• Manage clinical supplies in collaboration with vendors at both country and regional levels.

• Maintain study-specific and corporate tracking systems.

• Coordinate and conduct supervised monitoring visits.

• Manage site contracting and payment processes.

• Evaluate data integrity and compliance at the country/regional level.

• Prepare for and participate in site audits, coordinating the resolution of any audit findings.

• Oversee the development and implementation of Corrective and Preventive Actions (CAPA).

• Coordinate the review, management, and reporting of process deviations.

• Conduct initial training and authorization monitoring visits for Monitors, while mentoring newly promoted Lead CRAs.

• Deliver training sessions and presentations at Investigator Meetings.

• Ensure that subject recruitment targets and timelines are defined, communicated, documented, and achieved.

• Facilitate timely information exchange with trial sites regarding adverse events and protocol/process deviations.

• Supervise Site Management Associates in managing document and laboratory supply flows.

• Assist in the preparation of regulatory and ethics committee submission packages.

⛳️ Requirements

• Relevant educational background, such as MD, MPharm, RN, or a College/University degree in Life Sciences, or an equivalent combination of education, training, and experience.

• A minimum of 4 years of site monitoring experience, including participation in global clinical projects as a Lead Monitor or equivalent qualification.

• Experience with various types of monitoring visits in Phase II and/or III clinical trials.

• Strong experience in Oncology is preferred.

• Experience in Radiation Therapy, Radiopharmaceuticals, CAR-T Therapy, other forms of Cell Therapy, Gene Therapy, or Nuclear Medicine is advantageous.

• Strong experience in Gastrointestinal conditions (such as Crohn's disease, Ulcerative Colitis, IBS) is preferred.

• Full working proficiency in English is required.

• Proficiency in MS Office applications is necessary.

• Ability to plan, multitask, and work effectively in a dynamic team environment.

• Excellent communication, collaboration, and problem-solving skills.

• Willingness to travel as needed.

• A valid driver’s license (if applicable).

• PSI is not currently hiring individuals who require a work visa for employment or ongoing employment now or in the future.

🏝️ Benefits

• A stable, privately held Contract Research Organization (CRO) that has never undergone a merger or acquisition and has not experienced company-wide layoffs.

• A unique, leadership-focused CRA position with minimal travel and limited routine site assignments.

• Opportunities to mentor other CRAs and enhance your leadership skills.

• A collaborative, people-first culture where employees receive genuine support.

• Career development opportunities within a growing global organization.

• The opportunity to contribute to innovative clinical research that improves the lives of patients.