The College of Pharmacy Pharmaceutical Sciences department is seeking a highly skilled and experienced Clinical Research Coordinator Senior/Intermediate to lead and oversee the execution of various clinical trials. This role provides an exciting opportunity for candidates at either the senior or intermediate level based on experiences, skills, knowledge, independent clinical trial management ability for all aspects of clinical research projects. 

Study Coordination (30%):

• Coordinate all aspects of the clinical study, including subject 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 other biological samples.

Data Management (25%):

• Maintain accurate and up-to-date study records and documentation.
• Independently 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.
• Management and analysis of patient and laboratory data for clinical research projects.
• Prepare and present study reports, interim updates, and research findings to principal investigators and sponsors.

Compliance and Safety (25%):

• Submission and revision of clinical protocols
• 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.

Communication and Collaboration (20%):

• Communicate with IRB 
• Serve as the primary point of contact for study participants, addressing any questions or concerns.
• Collaborate with the research team, laboratory personnel, and external partners.
• Communicate study progress and issues to the principal investigators and sponsors.
• Prepare interim reports on participant enrollment and study progress 

• Bachelor's degree or higher in a related field (e.g., Nursing, Life Sciences, Public Health, pharmacy, biology, etc).
• Extensive clinical research experience, with senior-level candidates demonstrating leadership capabilities and independent project management skills.
• Excellent problem-solving skills and the ability to take a new perspective on existing challenges.
• Ability to work independently with minimal guidance, making informed decisions.
• Excellent communication and interpersonal skills and the ability to communicate effectively with participants, staff, and external partners.
• Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements.
• Excellent organizational and project/time management skills
• Proficiency in electronic data capture systems such as REDCap, Michart, billing calendar
• Proficiency in Microsoft Office Suite.
• Strong organizational, communication, and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders.
• Detail-oriented with strong problem-solving skills and the ability to adapt to evolving study requirements.
• Able to solve complex problems and develop innovative solutions to enhance research processes

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Salary may vary depending on qualifications, experience, and education of the selected candidate.

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.

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.