Clinical Research Specialist II — Study Coordinator

Cone Health Medical Group; Greensboro (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Cone Health Medical Group is seeking a Clinical Research Specialist II to support clinical research projects led by principal investigators. You will assist with subject follow-up visits, consent processes, data collection, and regulatory compliance.

The role involves coordinating site visits, preparing study materials, and ensuring accurate documentation and adherence to protocols. Experience in clinical settings and research consent is required.

Qualifications

• 2 years clinical experience; 1-year clinical research experience including consenting patients.
• High School Diploma or equivalent required.
• Ability to coordinate site visits and maintain regulatory documentation.

Responsibilities

• Perform simple clinical tasks to support subject follow-up visits (e.g., vital signs) and may perform more advanced tasks like ECG, PFT, phlebotomy, or drug administration.
• Collect data from patient charts, records, interviews, and tests, preparing documentation for reliable analysis.
• Assist in preparing and maintaining study materials and records for smooth research operations.
• Support regulatory controls, study procedures, and data management to ensure compliance with standards.
• Assist in regulatory submissions to IRB and department for protocol approvals.
• Coordinate site initiation, monitoring, and close-out visits and ensure protocol adherence.
• Recruit and screen prospective participants and obtain informed consent.
• Review biospecimen requirements and prepare specimens for shipment to reference labs.
• Prepare for site initiation, monitoring, and audits to maintain compliant processes.
• Perform other duties as assigned.

Skills

Clinical data collection

Regulatory compliance knowledge

Consent procedures

Study coordination

Education

High School Diploma or equivalent

Tools

ECG equipment

Phlebotomy supplies

Job description

Cone Health Medical Group is seeking a Clinical Research Specialist II to support clinical research projects led by principal investigators. You will assist with subject follow-up visits, consent processes, data collection, and regulatory compliance.

The role involves coordinating site visits, preparing study materials, and ensuring accurate documentation and adherence to protocols. Experience in clinical settings and research consent is required.