Cincinnati Children's Hospital Medical Center - Cincinnati, OH
posted 7 days ago
Full-time - Mid Level
Cincinnati, OH
Ambulatory Health Care Services
About the position
The Clinical Research Coordinator II or III at Cincinnati Children's Hospital plays a vital role in managing clinical research studies within the Hospital Medicine department. This position involves overseeing study conduct, ensuring regulatory compliance, and facilitating participant recruitment and retention. The coordinator will work closely with investigators and other clinical research professionals to ensure the successful execution of clinical trials, while also maintaining high standards of ethical practices and documentation.
Responsibilities
- Maintain awareness of status of all active studies and arrange for facilities and supplies.
- Ensure participant and study compliance, including collection of study specimens and study visits.
- Train others in specimen collection, processing, and storage procedures.
- Ensure specimens are properly logged, handled, and stored, maintaining all records required by regulatory agencies and sponsors.
- Serve as a resource for other clinical research professionals in conducting clinical trials.
- Collaborate with investigators and coworkers to ensure proper progress and completion of clinical studies.
- Prepare, submit, and maintain all regulatory submissions accurately and timely.
- Conduct self-audits of records to ensure audit-readiness and participate in monitor visits and audits.
- Oversee the review and approval of human research protocols with regulatory authorities.
- Document regulatory activities and maintain up-to-date records to support clinical research activities.
- Identify potential participants for research protocols and create a tracking system for enrollment.
- Conduct pre-consent screening to determine eligibility and execute the informed consent process.
Requirements
- Bachelor's degree in a related field or equivalent experience for Clinical Research Coordinator II; Master's degree or equivalent experience for Clinical Research Coordinator III.
- Experience in clinical research, including knowledge of regulatory requirements and Good Clinical Practice (GCP).
- Strong organizational skills and attention to detail.
- Excellent communication and interpersonal skills.
Nice-to-haves
- Certification in clinical research (e.g., ACRP or SOCRA certification).
- Experience with electronic data capture systems and clinical trial management software.
Benefits
- Health insurance coverage
- Dental insurance coverage
- 401k retirement savings plan
- Paid time off and holidays
- Tuition reimbursement for further education
- Professional development opportunities
