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Clinical Research Coordinator

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Onsite

Clinical Research Coordinator

Winaxis LLC

Clinical Research Coordinator

Skills

Google Cloud PlatformCompliance

1 month ago

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Important information


Contract type:

Permanent

Location:

Raleigh, NC, USA

Work mode:

Onsite

Published on:

9 September 2026

What they need


Job Title : Clinical Research Coordinator (CRC) Experience : 0

3 Years Location : Dallas, Texas Employment Type : Full-time Job Summary:- 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. Key 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 How to Apply Interested candidates can submit their updated resume along with a cover letter highlighting their clinical research experience, certifications, and relevant skills.

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