Clinical Research Coordinator
Winaxis LLC · Jersey City, NJ · 1 wk ago
On-siteAnalystFull-time
About the role
We are looking for a motivated and detail-oriented Clinical Research Coordinator to support the planning, execution, and management of clinical research studies. The ideal candidate should have 0–3 years of experience in clinical research and a strong understanding of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements. Fresh graduates with relevant internships or clinical research training are encouraged to apply.
Responsibilities
- Coordinate and manage clinical research studies in compliance with study protocols, ICH-GCP guidelines, and applicable regulations.
- Screen, recruit, and enroll study participants.
- Obtain informed consent from study participants.
- Schedule and coordinate patient visits and follow-up appointments.
- Collect, verify, and maintain accurate study documentation and source data.
- Enter clinical data into Electronic Data Capture (EDC) systems.
- Maintain Trial Master File (TMF), Investigator Site File (ISF), and essential study documents.
- Report adverse events and serious adverse events according to protocol and regulatory requirements.
- Coordinate with investigators, sponsors, CROs, and ethics committees.
- Prepare for monitoring visits, audits, and regulatory inspections.
- Ensure protocol compliance and participant safety throughout the study.
- Assist with study start-up, close-out activities, and regulatory submissions.
Required Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Microbiology, or a related field.
- 0–3 years of experience in clinical research or clinical trial coordination.
- Knowledge of ICH-GCP, FDA, and local regulatory guidelines.
- Familiarity with EDC systems and Microsoft Office.
- Strong organizational, communication, and documentation skills.
- Ability to work independently and as part of a multidisciplinary team.
Preferred Qualifications
- GCP Certification.
- Clinical Research certification is an added advantage.
- Experience with site coordination or patient recruitment.
- Knowledge of clinical trial documentation and regulatory submissions.
Key Skills
- Clinical Trial Coordination
- ICH-GCP Compliance
- Patient Recruitment
- Informed Consent Process
- Source Documentation
- Electronic Data Capture (EDC)
- Trial Master File (TMF)
- Regulatory Documentation
- Adverse Event Reporting
- Data Management
- Communication & Coordination
- Attention to Detail
- Time Management
Benefits
- Competitive salary
- Health insurance
- Performance-based incentives
- Training and career development opportunities
- Paid leave and holidays
- Exposure to global clinical research projects