We are seeking a detail-oriented and dedicated Clinical Research Coordinator (CRC) to manage and execute clinical trials at the site level. The CRC is responsible for coordinating all aspects of assigned research protocols, ensuring compliance with the study protocol, ICH Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements. This role serves as the primary liaison between the Principal Investigator (PI), the study participants, the Sponsor/CRO, and the Institutional Review Board (IRB).

Key Responsibilities

I. Subject Recruitment and Care

• Screening and Enrollment: Implement patient recruitment strategies, screen potential participants for eligibility against protocol criteria, and obtain Informed Consent in compliance with regulatory and ethical standards.
• Study Visits: Coordinate and conduct all required study visits and procedures (e.g., vital signs, ECGs, phlebotomy, physical assessments) according to the protocol schedule.
• Safety Monitoring: Monitor subjects for Adverse Events (AEs) and Serious Adverse Events (SAEs). Report all events promptly to the PI, Sponsor, and IRB as required by protocol and regulatory guidelines.
• Participant Retention: Maintain regular contact with study participants to promote adherence to the protocol and ensure high retention rates.

II. Data and Documentation Management

• Source Documentation: Develop and maintain accurate, detailed, and concurrent source documents for all study-related activities, ensuring data integrity and traceability.
• Data Entry: Accurately and timely enter clinical data into the Electronic Data Capture (EDC) system or case report forms (CRFs).
• Query Resolution: Respond promptly and effectively to data queries generated by the Sponsor/CRO, ensuring resolution within specified timelines.
• Record Keeping: Manage and maintain the Investigator Site File/Regulatory Binder, ensuring all essential regulatory documents are current, complete, and filed correctly.

III. Regulatory and Operational Compliance

• Regulatory Submissions: Prepare and submit necessary documents and reports to the IRB (e.g., protocol amendments, continuing reviews, safety reports) under the direction of the PI.
• Compliance: Adhere strictly to the study protocol, ICH-GCP, FDA regulations, and institutional Standard Operating Procedures (SOPs).
• Investigational Product (IP): Manage the investigational product (study drug/device) inventory, accountability logs, storage, and dispensation in compliance with regulatory requirements.
• Monitoring Visits: Facilitate and prepare for routine monitoring, auditing, and inspection visits by Sponsors, CROs, and regulatory agencies.

Qualifications and Requirements

• Education: Bachelor’s degree in a health-related or life science field is preferred. An Associate’s degree with significant clinical research experience may be considered.
• Experience: Minimum of 2-3 years of direct experience in clinical research coordination, or an equivalent combination of education and experience.
• Knowledge: Proven working knowledge of the research process, clinical trial terminology, and strict adherence to ICH Good Clinical Practice (GCP) guidelines and FDA regulations.
• Certifications: Current GCP Certification is required. Certification as a CCRP (Certified Clinical Research Professional) is highly desirable.

Skills and Competencies

• Detail Orientation: Exceptional attention to detail and accuracy in documentation and data management.
• Organizational Skills: Excellent planning, organizational, and time management abilities to handle multiple complex protocols simultaneously.
• Communication: Strong interpersonal, written, and verbal communication skills for effective interaction with patients, investigators, and external monitors.
• Technical Proficiency: Competence in using Electronic Data Capture (EDC) systems, electronic medical records (EMR), and Microsoft Office Suite.

Problem-Solving: Proactive and effective problem-solving skills to address challenges in recruitment, scheduling, and protocol deviations.

Job Types: Full-time, Part-time, Contract

Pay: $17.00 - $35.00 per hour

Benefits (FT only):

• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person