How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

The Program for Clinical Research in Dermatology (PCRiD) is seeking an experienced, positive, highly motivated, organized, autonomous individual with excellent communication and multi-tasking skills to join our growing research team. The Clinical Research Assistant will work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of dermatology clinical research studies. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities.

Responsibilities*

The Clinical Research Tech position's responsibilities include, but are not limited to the following:

Coordination and oversight of the regulatory process across multiple studies of different indications and phases, in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes independently
Assist with the preparation and submission of start-up regulatory packets to Sponsor and IRB
Create and maintain the administrative master site file required for the clinical research project
Responsible for the preparation, submission, and maintenance of IRB related documents
Ensures accuracy and congruency between IRB, regulatory documents and study documents
Confirm all investigators, staff and departments to be used for the study by maintaining staff updates in eResearch and delegation of authority logs; collect CV's and licenses; confirm IRB training requirements have been met and documented
Responsible for collection and storage of regulatory documents required by the clinical research project in compliance with federal and local regulations and guidelines
Maintains master files of all regulatory-related documents; files documents timely; reviews binders prior to monitor visits to ensure completeness
Meets with monitors during interim visits to review investigator site files
Responsible for keeping site documents up to date (IRB roster, lab certificates, etc.)
Track and document training of research staff to ensure compliance with rules and regulations associated with clinical research studies.
Monitor approval status of open studies by completing timely continuing reviews
Maintains master file of current CV's, licenses and training certificates
Maintains most up to date versions of study documents by completing timely amendments
Oversees document retrieval and archival process at study termination
Ability to be detail oriented
Ability to be organized
Ability to perform basic computer functions including SignNow
Ability to use customer service skills to provide an exceptional experience
Ability to work effectively within a team environment
Must be able to prioritize tasks; work well under stress, meet aggressive timelines, and problem solve to quickly and tactfully manage challenging situations concerning customer groups

Required Qualifications*

Associate degree in Health Science or an equivalent combination of related education and experience.
ONE of the following:
- Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
- An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
- Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.
Professional demeanor and excellent interpersonal and communication skills.
Experience with Microsoft Office products (i.e. Microsoft Word, Excel, and Power Point)
Confident and highly motivated with excellent multi-tasking ability and record-keeping skills.
Outstanding organizational skills with meticulous attention to detail.
Strong ability to work independently, exercising good judgement, with minimal supervision.
Ability to function with diverse teams of people in a diplomatic, collaborative, and effective manner.
Strong problem-solving skills.
Ability to adhere to established timelines to accomplish tasks.
Demonstrated ability to learn and use new skills quickly and effectively.
Able to maintain data confidentiality and participant/subject/patient privacy.
Excellent attendance record and strong work ethic.
Understanding of ICH-GCP guidelines, OHRP, HIPAA, and FDA regulations

Desired Qualifications*

Bachelor or Master's degree
Research experience including direct interaction with research patients in a patient care setting or outpatient clinic
Some familiarity with REDCap, OnCore, Epic, MiCHART, and eResearch applications
IRB/regulatory experience

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Additional Information

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

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.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.