Clinical Research Assistant

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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.

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 Assistant 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*

• High school diploma or GED is necessary

• Associate's degree in a relevant field of study and/or equivalent experience in a health sciences discipline

• 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

Additional Information

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.

Job Detail

Job Opening ID

247805

Working Title

Clinical Research Assistant

Job Title

Clinical Research Assistant

Work Location

Ann Arbor Campus

Ann Arbor, MI

Full/Part Time

Full-Time

Regular/Temporary

Regular

FLSA Status

Nonexempt

Organizational Group

Medical School

Department

MM Dermatology Department

Posting Begin/End Date

5/16/2024 - 6/06/2024

Career Interest

Research

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