Job Information
University of Michigan Clinical Study Coordinator in Ann Arbor, Michigan
Clinical Study Coordinator
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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*
Bachelor's 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.
Job Detail
Job Opening ID
249934
Working Title
Clinical Study Coordinator
Job Title
Clinical Subjects Coordinator
Work Location
Ann Arbor Campus
Ann Arbor, MI
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Nonexempt
Organizational Group
College Pharmacy
Department
PHARMACY Clinical Pharmacy
Posting Begin/End Date
6/04/2024 - 7/04/2024
Career Interest
Research
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