What are the responsibilities and job description for the Clinical Research Coordinator position at Winaxis LLC?
Job Summary
We are seeking a detail-oriented Clinical Research Coordinator to oversee and manage clinical trials and research studies. The ideal candidate will ensure compliance with regulatory guidelines, coordinate study activities, and support investigators in executing clinical research protocols.
Key Responsibilities
Clinical Trials, ICH-GCP, Patient Recruitment, Regulatory Compliance, EDC, CTMS, Data Collection, Documentation, Communication
We are seeking a detail-oriented Clinical Research Coordinator to oversee and manage clinical trials and research studies. The ideal candidate will ensure compliance with regulatory guidelines, coordinate study activities, and support investigators in executing clinical research protocols.
Key Responsibilities
- Coordinate and manage clinical trials in accordance with study protocols
- Recruit, screen, and enroll study participants
- Obtain informed consent from participants
- Maintain accurate and complete study documentation and records
- Ensure compliance with regulatory requirements (FDA, ICH-GCP, IRB)
- Collect, process, and report clinical data
- Monitor patient safety and report adverse events
- Liaise with investigators, sponsors, and regulatory authorities
- Schedule study visits and follow-ups
- Experience in clinical research or healthcare setting
- Knowledge of clinical trial processes and regulations (ICH-GCP guidelines)
- Strong organizational and documentation skills
- Excellent communication and interpersonal skills
- Attention to detail and ability to multitask
- Certification such as CCRP (Certified Clinical Research Professional) or CCRC
- Experience with Electronic Data Capture (EDC) systems
- Familiarity with clinical trial management systems (CTMS)
- Prior experience working with sponsors or CROs
Clinical Trials, ICH-GCP, Patient Recruitment, Regulatory Compliance, EDC, CTMS, Data Collection, Documentation, Communication