Clinical Research Coordinator (Onsite)

Position Summary:

The Research Coordinator is responsible for coordinating multiple clinical research protocols and serving as a liaison among investigators, sponsors, and internal departments. Under direct supervision, this role develops a foundational understanding of human subject research operations and regulatory requirements.

Key Responsibilities:

• Adhere to Code of Conduct, Mission, and Values of HRI.

• Complete assigned training by specified deadlines.

• Coordinate operational activities for multiple clinical trials.

• Serve as liaison among site research staff, sponsors, and supervisors.

• Collaborate with departments including finance, hospital administration, and IRBs.

• Manage study timelines from feasibility to closeout.

• Review study design and patient eligibility with physicians and participants.

• Ensure informed consent and protocol compliance for subject protection.

• Monitor and verify data integrity via source documentation.

• Create and maintain source documentation tools if not provided by the sponsor.

• Collect, complete, and input data into case report forms or electronic systems.

• Manage logistics for study drug/device shipments and supplies.

• Track adverse events, deviations, waivers, and violations.

• Communicate study-related issues to appropriate personnel or management.

• Participate in study meetings, monitoring visits, and team calls as required.

• Respond to monitoring/audit findings appropriately.

Education & Experience:

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

• Preferred: Degree in a healthcare or science-related field.

• Certification: Certified Clinical Research Coordinator (preferred).

Knowledge, Skills & Abilities:

Knowledge:

• Understanding of organizational policies and clinical research guidelines (ICH, CFR).

• Basic medical terminology.

Skills:

• Effective communication and organizational skills.

• Time management and attention to detail.

• Basic clinical trial tasks (e.g., ECG, phlebotomy, specimen processing and shipping).

Abilities:

• Strong interpersonal skills.

• Self-motivation and accuracy-driven mindset.

Clinical Competencies:

May require hands-on clinical tasks including ECGs, phlebotomy, and specimen handling. Competency assessments and necessary training provided per protocol requirements.

Travel Requirements:

• Occasional Travel: Up to 25% as required.