In House Clinical Research Associate II – FSP

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Act as the primary liaison for project teams and investigative sites; perform and document site communications.

• Evaluate site performance and collaborate with the CRA to implement action plans.

• Monitor patient recruitment efforts and engage in discussions about study risks and opportunities with the Project Manager and CTL.

• Support CRAs with preparation for site visits, generating reports, quality control of files, and resolving action items.

• Oversee activities related to site maintenance, renewals, and the documentation required by regulatory bodies/IRB/IEC.

• Conduct reviews of Case Report Forms, generate queries, and resolve issues within data management systems.

• Aid in on-site monitoring activities, which include reviewing CRFs, conducting Source Data Review/Source Data Verification, managing regulatory files, and ensuring drug accountability.

• Carry out remote monitoring visits, including SDV/SDR following MEA training.

• Coordinate with laboratories, sponsors, medical monitors, project teams, CTAs, and investigative sites.

• Provide training to sites through phone or web meetings.

• Manage the review and reconciliation of IVRS/IWRS.

• Organize study visits and oversee the shipment of drugs and laboratory samples.

• Ensure site compliance with protocol requirements, visit schedules, and timelines.

• Distribute and monitor clinical trial supplies.

• Enter weekly study data into CTMS and assist in the preparation of status reports.

• Provide support for submissions and notifications to Ethics Committees and Regulatory Authorities.

• Facilitate the translation and back-translation of study documents.

• Participate in and present at investigator, sponsor, kick-off, and face-to-face meetings.

• Ensure adherence to Fortrea SOPs, regulatory standards, ICH-GCP, and all relevant guidelines.

• Complete the Fortrea Monitoring Excellence Academy training program.

• Perform additional project-related administrative tasks as assigned.

⛳️ Requirements

• A university or college degree (preferably in biological or life sciences), or certification in a relevant allied health profession from a recognized institution (e.g., nursing licensure, medical or laboratory technology).

• Candidates with two or more years of pertinent clinical research experience in the pharmaceutical or CRO sectors may be considered in lieu of the above qualification.

• Fundamental understanding of ICH-GCP guidelines.

• Basic knowledge of the clinical trial process.

• A minimum of two years of experience in a related industry role.

• Capability to monitor study sites in accordance with protocol monitoring guidelines, SOPs, ICH Guidelines, and GCP.

• Ability to collaborate effectively within a project team.

• Strong planning, organizational, time management, and problem-solving abilities.

• Excellent oral and written communication skills.

• General proficiency in computer usage.

• Ability to work efficiently and effectively in a matrix environment.

• Capability to sit for extended durations and operate a vehicle safely.

• Proficient in using various computer software applications.

• Ability to lift and carry light to moderate loads of up to 15–20 lbs.

• Consistent and reliable attendance is required.

• Flexibility in working hours may be necessary.

🏝️ Benefits

• Comprehensive health insurance.

• Retirement savings plan with company match.

• Opportunities for professional development and training.

• Flexible working arrangements.

• Generous paid time off and holiday policies.