Clinical Research Coordinator Job at Winaxis, Delaware, OH

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  • Winaxis
  • Delaware, OH

Job Description

About Us

We are dedicated to advancing healthcare through innovative clinical research. Our mission is to ensure the highest standards of patient care and scientific integrity in every study we conduct. We are seeking a motivated Clinical Research Coordinator (CRC) to join our team and manage day-to-day clinical trial activities while maintaining compliance with regulatory and ethical standards.

Key Responsibilities
  • Coordinate and oversee all aspects of assigned clinical research studies.

  • Recruit, screen, and enroll study participants in accordance with protocol requirements.

  • Conduct informed consent discussions and ensure proper documentation.

  • Schedule study visits and perform follow-up assessments with participants.

  • Collect, record, and maintain accurate source documentation and case report forms (CRFs).

  • Ensure adherence to study protocols, Good Clinical Practice (GCP), and institutional policies.

  • Communicate effectively with investigators, sponsors, and regulatory authorities.

  • Manage investigational product accountability and inventory.

  • Support monitoring visits, audits, and inspections.

  • Assist in report preparation and data analysis as required.

Required Skills & Qualifications
  • Bachelor's degree in Life Sciences, Nursing, Healthcare, or a related field.

  • Thorough knowledge of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.

  • Strong attention to detail, documentation accuracy, and organizational skills.

  • Proficiency with EDC systems and MS Office applications.

  • Excellent communication and interpersonal skills.

  • Ability to manage multiple studies and prioritize tasks effectively.

Nice to Have
  • Certified Clinical Research Coordinator (CCRC) credential.

  • Experience with Phase I IV clinical trials.

  • Familiarity with IRB submissions and site initiation procedures.

  • Prior experience in oncology, pharmaceuticals, or medical device studies.

What We Offer
  • Competitive compensation and benefits package.

  • Opportunity to contribute to impactful clinical research projects.

  • Supportive and collaborative work environment.

  • Ongoing professional development and certification support.

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