Jobs · Analyst · New Jersey

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

Similar jobs

Clinical Research Coordinator

Elite Clinical NetworkSan Antonio, TX· 1 wk ago
Information Technologyapply on eliteclinicalnetwork.clearcompany.com