Lead Clinical Research Associate

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

📋 Description

• Provide guidance, oversight, and mentorship for regional clinical trials

• Collaborate with Project Managers, Regional Project Leads, CRAs, and cross-functional teams to ensure the delivery of high-quality study execution

• Oversee project timelines, patient enrollment, data cleaning, and adherence to compliance

• Implement corrective and preventive actions

• Review monitoring visit reports and guarantee regional reporting compliance

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

• Lead project team calls at the country level and provide status updates to Regional Leads and Project Managers

• Deliver project-specific training and develop 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 oversee the reconciliation of Investigator Site File/TMF

• Safeguard site-level data integrity and compliance

• 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 with vendors at both country and regional levels

• Update study-specific and corporate tracking systems

• Coordinate and conduct supervised monitoring visits

• Handle site contracting and payment processes

• Assess data integrity and compliance at the country/regional level

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

• Oversee the development and implementation of CAPA

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

• Conduct initial training and authorization monitoring visits for Monitors

• Mentor newly promoted Lead CRAs

• Deliver trainings and presentations during Investigator Meetings

• Ensure that subject recruitment targets 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 managing document and laboratory-supply flows

• Assist in preparing regulatory and ethics committee submission packages

⛳️ Requirements

• Relevant educational qualifications 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' experience in site monitoring with involvement in global clinical projects as a Lead Monitor or an equivalent qualification level

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

• Significant experience in Oncology is preferred

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

• Strong experience in GI disorders (e.g., Crohn's, Ulcerative Colitis, IBS) is preferred

• Full working proficiency in English

• Proficient 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 hiring individuals requiring a work visa for employment or continued employment now or in the future

🏝️ Benefits

• A stable, privately held CRO that has never undergone a merger or acquisition and has not experienced company-wide layoffs

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

• Opportunities to mentor fellow CRAs and enhance your leadership skills

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

• Career development prospects within a growing global organization

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