Lead Clinical Research Associate

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

📋 Description

• Lead, oversee, and provide mentorship for regional clinical trials

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

• Oversee project timelines, patient enrollment, data cleaning, and compliance; implement corrective and preventive actions as necessary

• Review monitoring visit reports and ensure adherence to regional reporting requirements

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

• Conduct country-level project team calls and deliver status updates to Regional Leads and Project Managers

• Provide project-specific training and develop training materials

• Supervise source data verification, follow up on data queries, and manage site-level study risks

• Ensure appropriate handling, accountability, reconciliation, and return of investigational products and clinical study supplies

• Review essential study documents and oversee ISF/TMF reconciliation

• Maintain site-level data integrity and compliance

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

• Manage query resolution, including observations from Central Monitoring

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

• Oversee clinical supplies management with vendors at both country and regional levels

• Maintain study-specific and corporate tracking systems

• Organize supervised monitoring visits and conduct those visits

• Handle site contracting and payments

• Prepare for audits, participate in site audits, and coordinate the resolution of audit findings

• Oversee the development and implementation of CAPA

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

• Conduct initial training and authorization monitoring visits for Monitors

• Mentor newly promoted Lead CRAs

• Lead trainings and presentations at Investigator Meetings

• Ensure that subject recruitment targets and project timelines are established, communicated, documented, and achieved

• Ensure timely and accurate information flow with trial sites concerning Adverse Events and protocol/process deviations

• Supervise Site Management Associates in document and laboratory-supply processes

• 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 a comparable combination of education, training, and experience

• At least 4 years of site monitoring experience

• Involvement 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 Oncology expertise is preferred

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

• Strong experience in GI, including Crohn’s disease, Ulcerative Colitis, or IBS, is preferred

• Full working proficiency in English

• Proficient in MS Office applications

• Ability to plan, multitask, and thrive in a dynamic team environment

• Excellent communication, collaboration, and problem-solving skills

• Willingness to travel

• Valid driver’s license, if applicable

• Must not require a work visa for employment or continued employment now or in the future

🏝️ Benefits

• Stable, privately held CRO with no mergers, acquisitions, or company-wide layoffs

• Unique leadership-focused CRA role with minimal travel and little to no routine site assignments

• Opportunities to mentor other CRAs and enhance leadership skills

• Collaborative, people-first culture

• Career development opportunities within a growing global organization

• Chance to contribute to innovative clinical research that positively impacts patients' lives