Clinical Study Coordinator

1 week ago

Ann Arbor, Michigan, United States University of Michigan Full time
Summary

The College of Pharmacy Pharmaceutical Sciences department is seeking a highly organized and motivated Clinical Study Coordinator to oversee the execution of a pharmacokinetic study involving modified release (MR) drug products in healthy volunteers. This study aims to characterize the pharmacokinetics of two MR drug products and to collect gastrointestinal (GI) physiology through GI intubation study.

Responsibilities

Study Coordination:

  • Coordinate all aspects of the clinical study, including volunteer recruitment, screening, enrollment, and follow-up.
  • Schedule and manage study visits, ensuring adherence to the study protocol.
  • Administer informed consent and ensure ethical compliance
  • Provide logistical support by managing inventory and supply of study materials and medication.
  • Oversee the collection of biological samples (blood, urine, feces) and GI fluid through intubation.

Data Management:

  • Maintain accurate and up-to-date study records and documentation.
  • Collect, record, and manage participant data to maintain accurate study records, ensuring confidentiality and integrity of data in accordance with regulatory guidelines
  • Assist in the preparation of study reports and presentations.

Compliance and Safety:

  • Ensure all study activities comply with regulatory requirements and ethical standards.
  • Monitor volunteers for adverse events and report them in accordance with study protocols.
  • Maintain the confidentiality of all study participants and their data.

    Required Qualifications
    • Bachelors degree in a related field (e.g., Nursing, Life Sciences, Public Health, pharmacy, biology, etc).
    • Previous experience in clinical research
    • Excellent communication and interpersonal skills.
    • Knowledge of Good Clinical Practice (GCP) and regulatory requirements.
    • Excellent organizational and project/time management skills
    • Strong ability to communicate effectively with participants, staff, and external partners.
    • Experience with electronic data capture systems and proficiency in Microsoft Office Suite.
    • Detail-oriented with strong problem-solving skills and the ability to adapt to evolving study requirements.

      Additional Information An overnight shift is required when conducting the clinical study procedures (about 1x/month, typically on a Friday night into Saturday). The schedule of the coordinator will be adjusted that week to accommodate the change in schedule. Background Screening The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act. U-M EEO/AA Statement The University of Michigan is an equal opportunity/affirmative action employer. PDN-9c3602b cb-b65e-8f48c063849d

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