Clinical Research Coordinator (Onsite)

Position Summary:
The Research Coordinator is responsible for managing multiple clinical research protocols while serving as a key liaison between site investigators and sponsors. This role operates under direct supervision and is designed to develop expertise in clinical research operations, compliance, and patient protection.

Key Responsibilities:

• Coordinate daily operations of research studies from feasibility through closeout.

• Act as liaison between site personnel, sponsors, and supervisors.

• Collaborate with finance, hospital administration, and IRB (if applicable).

• Schedule and track assessments and study milestones.

• Review study protocols with physicians and patients to ensure eligibility compliance.

• Ensure proper informed consent and adherence to protocol and regulatory standards.

• Enter and verify clinical data in Case Report Forms or electronic systems.

• Create source documentation tools when not provided by sponsors.

• Monitor and report adverse events, protocol deviations, and waivers.

• Manage study supplies, including drug and device shipments.

• Attend investigator meetings, site visits, audits, and training sessions.

• Respond to monitoring and audit findings.

Education & Experience:

• Required: Bachelor's degree and 1+ year of relevant research experience (or equivalent).

• Preferred: Certified Clinical Research Coordinator (CCRC).

Knowledge, Skills & Abilities:

• Knowledge:

  • Basic clinical research operations, ICH-GCP guidelines, and federal regulations.

  • Understanding of medical terminology and internal SOPs.

• Skills:

  • Effective communication and time management.

  • Clinical trial skills such as ECG acquisition, phlebotomy, and specimen handling.

• Abilities:

  • Strong attention to detail, self-motivation, and interpersonal skills.

  • Ability to manage multiple tasks in a regulated environment.

Clinical Competencies:

Annual demonstration of clinical skills (e.g., ECG, specimen processing) may be required. Training and certification will be provided as necessary per protocol.

Travel Requirements:

☒ Occasional Travel (up to 25%)
☐ No Travel
☐ 50% or more