Job Description
Summary
The Clinical Research Coordinator (CRC) is responsible for coordinating and executing clinical research studies in compliance with regulatory requirements and institutional guidelines. Additionally, the position will be responsible for maintaining study database, completing study documents, recruiting study patients, and preparing/conducting monitor and auditor visits. The CRC ensures the integrity of study data, subject safety, and protocol adherence while working closely with investigators, sponsors, and clinical teams. Some travel is required.
Entity Medical University Hospital Authority (MUHA)
Worker Type Employee
Worker Sub-Type Regular
Cost Center CC005146 COL - Research Service Center - Columbia
Pay Rate Type Salary
Pay Grade Health-28
Scheduled Weekly Hours 40
Work Shift Job Title: Clinical Research Coordinator
Location: MUSC Columbia Medical Center Downtown
Entity: MUHA
Worker Type: Employee
Worker Sub-Type: Pay Rate Type: Non-Exempt
Scheduled Weekly Hours: 40
Summary The Clinical Research Coordinator (CRC) is responsible for coordinating and executing clinical research studies in compliance with regulatory requirements and institutional guidelines. Additionally, the position will be responsible for maintaining study database, completing study documents, recruiting study patients, and preparing/conducting monitor and auditor visits. The CRC ensures the integrity of study data, subject safety, and protocol adherence while working closely with investigators, sponsors, and clinical teams. Some travel is required.
Job Duties Responsibility Description 1. Study Coordination & Execution Coordinate day-to-day operations of assigned clinical trials, including subject recruitment, scheduling, and visit management.
2. Regulatory Compliance & Documentation Prepare and maintain IRB submissions, regulatory binders, informed consent documents, and other essential documents. Ensure compliance with FDA, GCP, ICH, and institutional policies.
3. Data Collection & Management Collect, enter, and review study data in case report forms (CRFs) or electronic data capture (EDC) systems. Perform data queries and ensure accuracy and completeness.
4. Participant Interaction & Informed Consent Conduct informed consent discussions and maintain ongoing communication with participants throughout the study to ensure adherence and safety.
5. Sponsor & Monitor Communication Liaise with sponsors, CROs, and monitors during site initiation, monitoring visits, and close-outs. Ensure timely query resolution and protocol adherence.
6. Training & Education Stay current with regulatory requirements and clinical research practices. Participate in ongoing training and continuing education. May assist in training new staff.
7. Budget & Financial Tracking Support budget development and track participant stipends and study-related billing. Communicate with finance teams as needed.
8. Other Duties as Required Other duties as assigned
Qualifications -- Bachelor's degree in a health-related field or equivalent combination of education and experience; Bachelor RN preferred but not required.
- Working knowledge of GCP, FDA regulations, and clinical trial operations
- Familiarity with medical terminology, HIPAA, or Good Clinical Practice (GCP)
- Excellent communication, organization, and interpersonal skills
- Ability to collect, organize and analyze information in a clear and concise manner
- Proficiency with EDC systems, Microsoft Office Suite, and medical terminology
Additional Knowledge and Skills Preferred
- Minimum 1-2 years of experience in clinical research coordination preferred
- Prior exposure to clinical research in an academic, hospital, or lab setting (through coursework, volunteering, or work-study)
- Laboratory or phlebotomy experience is preferred but not required
- Certification as a Clinical Research Coordinator (e.g., ACRP or SOCRA) is a plus
Working Conditions
- Standard office and clinical setting
- May require occasional travel to satellite locations or sponsor meetings
- Must be able to work flexible hours to accommodate patient schedules or protocol requirements
Additional Qualifications -- Bachelor's degree in a health-related field or equivalent combination of education and experience; Bachelor RN preferred but not required.
- Working knowledge of GCP, FDA regulations, and clinical trial operations
- Familiarity with medical terminology, HIPAA, or Good Clinical Practice (GCP)
- Excellent communication, organization, and interpersonal skills
- Ability to collect, organize and analyze information in a clear and concise manner
- Proficiency with EDC systems, Microsoft Office Suite, and medical terminology
Additional Knowledge and Skills Preferred
- Minimum 1-2 years of experience in clinical research coordination preferred
- Prior exposure to clinical research in an academic, hospital, or lab setting (through coursework, volunteering, or work-study)
- Laboratory or phlebotomy experience is preferred but not required
- Certification as a Clinical Research Coordinator (e.g., ACRP or SOCRA) is a plus
If you like working with energetic enthusiastic individuals, you will enjoy your career with us!
The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.
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Job Tags
Full time, Work at office, Flexible hours, Shift work,