Lead Clinical Research Associate

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

📋 Description

• Lead, supervise, and mentor teams involved in regional clinical trials.

• Collaborate with Project Managers, Regional Project Leads, CRAs, and interdisciplinary teams to guarantee high-quality execution of studies.

• Emphasize leadership, mentorship, oversight, and uniformity in monitoring practices rather than direct site management, featuring minimal to no site assignments and a low-travel model.

• Oversee project timelines, patient enrollment, data cleaning, and adherence to compliance; take corrective and preventive actions as necessary.

• Evaluate monitoring visit reports and guarantee compliance with regional reporting standards.

• Serve as the primary communication liaison among Monitors, Site Management Associates, Regional Project Leads, and Project Managers.

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

• Deliver project-specific training and develop training materials.

• Supervise source data verification, address data queries, and manage study risks at the site level.

• Ensure appropriate handling, accountability, reconciliation, and return of Investigational Products and clinical study supplies.

• Review essential study documents and oversee reconciliation of ISF/TMF files.

• Safeguard data integrity and compliance at both site and country/regional levels.

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

• Guide Monitors in resolving queries, including those from Central Monitoring.

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

• Oversee clinical supplies in coordination with vendors at both country and regional levels.

• Maintain study-specific and corporate tracking systems.

• Coordinate and conduct supervised monitoring visits.

• Handle site contracting and payment processes.

• Conduct audit preparation visits, participate in site audits, and manage the resolution of findings.

• Supervise the development and implementation of CAPA.

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

• Conduct initial training and authorization visits for Monitors; mentor newly promoted Lead CRAs.

• Present trainings and presentations at Investigator Meetings.

• Ensure that subject recruitment goals and project timelines are clearly defined, communicated, documented, and achieved.

• Ensure timely communication with trial sites regarding Adverse Events and protocol/process deviations.

• Supervise Site Management Associates in handling documents and laboratory supplies.

• Assist in preparing 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.

• At least 4 years of site monitoring experience with involvement in global clinical projects as a Lead Monitor or at an equivalent qualification level.

• Experience with all types of monitoring visits in Phase II and/or III.

• Strong experience in Oncology is preferred.

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

• Strong experience in Gastrointestinal issues (Chron's, Ulcerative Colitis, IBS) is preferred.

• Full working proficiency in English.

• Proficiency in MS Office applications.

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

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

• Willingness to travel.

• Valid driver’s license (if applicable).

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

🏝️ Benefits

• A stable, privately held CRO that has never gone through a merger or acquisition and has never had company-wide layoffs.

• A distinctive leadership-focused CRA position with minimal travel and few to no regular site assignments.

• Opportunities to mentor fellow CRAs and enhance your leadership capabilities.

• A collaborative, people-first culture that genuinely supports employees.

• Career development opportunities within a growing global organization.

• The opportunity to contribute to innovative clinical research that enhances patients' lives.