Contract – Clinical Research Coordinator

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

📋 Description

• Recruit, enroll, and follow up with study participants in clinical trials under the guidance of the Principal Investigator and Project Manager.

• Coordinate trial participation in accordance with protocols, SOPs, GCP/ICH guidelines, FDA regulations, and other relevant regulations.

• Engage in clinical trial activities from study initiation through planning, execution, and conclusion.

• Attend investigator, project, and departmental meetings and training sessions; lead when necessary and prepare meeting minutes.

• Serve as a temporary Project Manager for smaller studies when required.

• Assess participant eligibility alongside study investigators.

• Screen potential participants, present trial information, facilitate informed consent, and enroll participants.

• Assist in the development, review, and distribution of protocols, consent forms, study instructions, manuals, guidelines, and study tools.

• Coordinate patient care, provide education on medication administration when applicable, and ensure investigational drug accountability.

• Monitor changes in participant conditions, adverse events, concomitant medications, protocol adherence, and responses to the study drug; document findings accordingly.

• Collect, document, enter, and report data accurately and in a timely manner; schedule and participate in monitoring and audits.

• Maintain knowledge and ensure compliant execution of assigned research protocols and regulatory obligations.

• Keep consent forms, case report forms, SAEs, source documents, and regulatory documents organized within the ISF.

• Oversee clinical research project logistics while supporting enrollment and retention objectives.

• Participate in training and educate personnel and vendors regarding clinical research practices.

• Collaborate with Project Managers, investigators, vendors, sponsors, sites, and multidisciplinary teams.

• Offer process-improvement solutions and assist with their implementation.

• Uphold participant confidentiality in accordance with HIPAA and provide a secure research environment.

• Mentor and train other Clinical Research Coordinators (CRCs) and support the CRC team.

• For hybrid trials: act as the site/Sponsor point of contact, develop project and communication plans, and aid in site study execution.

⛳️ Requirements

• Bachelor’s degree (preferred) or at least a two-year college degree, or an equivalent combination of education, training, experience, and demonstrated skills.

• An advanced degree is preferred but not mandatory.

• A minimum of 5 years of experience in pharmaceutical-sponsored clinical research is necessary or equivalent education, training, and experience in the clinical research field.

• ACRP (CCRC) or SoCRA (CCRP) certification is highly desirable.

• Experience working with patients in a HIPAA-compliant environment.

• Familiarity with Good Clinical Practice (GCP) and applicable regulatory requirements.

• Medical and scientific knowledge is preferred.

• Strong time management and organizational skills; ability to handle multiple tasks simultaneously.

• Keen attention to detail and accuracy.

• Capability to collaborate effectively with cross-functional team members.

• Expertise in trial management and clinical research.

• In-depth knowledge of FDA regulations and GCP guidelines.

• Excellent written and verbal communication and presentation skills.

• Proficiency in MS Office and Google Suite applications.

• Experience using proprietary software.

• Ability to adapt to a rapidly evolving environment and work within a decentralized team structure.

• Proficient in English communication, both verbal and written.

• May require extended or atypical work hours depending on research needs and business requirements.

🏝️ Benefits

• Opportunity to transition to Full Time after 6 months.

• Up to 20% travel required, as needed, for project team meetings, client presentations, and other professional meetings/conferences.

• Commitment to equal opportunity and affirmative action employment.