Job Vacancy: Clinical Research Coordinator




Responsibilities:

Assumes responsibility for effective management of research protocols initiated at Great Lakes Research Institute including but not limited to:


  • Patient recruitment and consent, Scheduling and retention in addition to scheduled visits for study events

  • Creates protocol specific documentation reference tools and source documents

  • Management of patient visits, documentation and binders for the study.

  • Responsible for day-to-day regulatory management including, DOA, SAE reporting, deviations, and amendment review.

  • Assures adherence to safety guidelines and protocol schedule for patient treatment with oversight of the Principal and Sub-Investigators.

  • Organization and coordination of Monitor/audit visits as required

  • Responsible for EDC data entry and addressing of any queries generated

  • Additional responsibilities will be assigned as needed

Minimum Qualifications:

· Three years of relevant experience in clinical research

· Blood draw experience

· Experience with EDC and Source Data (eSource a plus)

· Basic understanding of regulatory

· Experience with Microsoft Office


Skills:

  • Knowledge of good clinical practice, FDA, OHRP, HIPAA policies

  • Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.

  • Confident self-starter


Send your resume to info@greatlakesresearch.org

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