Job Title: Lead Clinical Research Coordinator

Summary:

We are seeking a highly motivated and experienced Lead Clinical Research Coordinator to join our dynamic team. The ideal candidate will have extensive experience working on clinical trials, strong communication skills, exceptional organizational abilities, and the ability to thrive in a fast-paced environment. The Lead Research Coordinator will play a critical role in coordinating and overseeing various aspects of clinical research studies, ensuring compliance with protocols, and maintaining effective communication with sponsors, investigators, and site staff.

Responsibilities:

• Strong Communication:
  • Serve as the main contact for the research site, ensuring timely responses to queries and requests from Clinical Research Associates (CRAs) and sponsors within 24 hours.
  • Handle Investigator Site File (ISF) document requests, Electronic Data Capture (EDC) queries, and protocol-related questions, maintaining clear and effective communication channels to facilitate the site's success.
  • Utilize strong communication skills and protocol understanding to pre-screen subjects effectively.
• Teamwork:
  • Collaborate effectively within a small team environment, recognizing the importance of teamwork in achieving success in clinical research studies.
  • Work closely with fellow team members to ensure seamless coordination and execution of research activities.
• Adaptable/Multitasking:
  • Demonstrate adaptability by efficiently transitioning between different studies and confidently managing various sponsor protocols.
  • Multitask effectively to handle multiple ongoing studies, prioritizing tasks as needed to ensure the department's success.
• Organized/Detail Oriented:
  • Maintain a high level of organization to handle multiple studies simultaneously, preventing protocol mix-ups, and paying meticulous attention to detail.
  • Ensure all documentation and records are accurate, up-to-date, and compliant with state and federal regulations.

Monthly Tasks:

• Order Envi/McKesson supplies for patient rooms.
• Order study supplies through assigned lab portals, including the destruction of expired kits onsite.
• Review site regulatory documents and lab certificates to ensure compliance with regulations.
• Coordinate research schedules with Principal Investigators (PIs) and staff.
• Schedule specimen pickups with Marken/UPS.
• Attend virtual Investigator Meetings and Site Initiation Visits (SIVs), lead monitoring visits, and close-out visits.

Daily/Weekly Tasks:

• Check Institutional Review Board (IRB) website for updates on approved versions of Informed Consent Forms (ICF), Protocol Amendments (PA), Investigator Brochures (IB), and recruitment materials.
• Implement necessary actions for new releases of ICF, PA, and IB.
• Maintain Investigator Site Files (ISF) for ongoing studies in Paper ISF, GDrive, and sponsor portals.
• Coordinate with CRAs on monitoring follow-up letters.
• Conduct study visits for various ongoing studies, adhering to the Schedule of Activities (SOA).

Qualifications:

• Bachelor's degree in a related field (preferably healthcare or life sciences).
• Minimum of 2-3 years of experience as a clinical research coordinator in clinical trials.
• Strong understanding of GCP regulations and clinical trial processes.
• Excellent communication skills, both verbal and written.
• Ability to work independently and as part of a team.
• Proficient in Microsoft Office Suite and EDC systems.
• Detail-oriented with exceptional organizational skills.

Preferred Qualifications:

• Certification as a Clinical Research Coordinator (CCRC)
• Experience with various therapeutic areas and study phases.
• Familiarity with regulatory requirements and IRB processes.