Lead Clinical Research Coordinator

Job Summary

We are seeking a highly organized and motivated Lead Clinical Research Coordinator (CRC) with experience in Phase I clinical trials to join our research team. The Lead CRC will oversee and coordinate all aspects of clinical research studies, ensuring adherence to protocols, regulatory compliance, and the highest standards of patient care. This role requires flexibility, as responsibilities may include weekday and weekend coverage.

Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as the position may involve specimen collection and basic clinical procedures.

Key Responsibilities

• Lead and coordinate day-to-day clinical research activities, particularly Phase I studies, to ensure compliance with study protocols.
• Recruit, screen, and enroll study participants, ensuring eligibility and proper documentation.
• Obtain informed consent and ensure ethical conduct in all participant interactions.
• Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples).
• Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs).
• Maintain accurate and timely documentation in case report forms and electronic data capture systems.
• Communicate effectively with sponsors, monitors, and IRBs regarding study progress, compliance, and audit readiness.
• Schedule and manage participant visits, including weekday and weekend appointments, ensuring visit windows are met.
• Ensure proper handling, accountability, and storage of investigational products.
• Maintain regulatory documents and assist with IRB submissions.
• Mentor and guide junior CRCs and research staff as needed.
  
  

Qualifications

• Bachelor’s degree in a health-related field or equivalent experience.
• Minimum 2–3 years of experience in clinical research, with at least 1 year in Phase I studies strongly preferred.
• Phlebotomy certification or MA certification preferred.
• Strong knowledge of Good Clinical Practice (GCP) and regulatory guidelines (FDA, ICH).
• Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
• Strong interpersonal and communication skills with patients, staff, and external stakeholders.
• Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms).
• Ability to work independently and as part of a multidisciplinary team.
• Flexibility to work weekdays and weekends as required by study schedules.
  
  

Preferred Qualifications

• Familiarity with IRB processes, study start-up, and regulatory documentation.
• Experience mentoring or leading junior clinical research staff.
• Bilingual skills (depending on patient population) are a plus.