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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 Mary H. Weiser Food Allergy Center is seeking a highly motivated clinical research Associate/Intermediate for multiple clinical research studies, ranging from moderate to complex investigating the development of and new treatment modalities for food allergies. 

As a clinical research Associate for The Mary H. Weiser Food Allergy Center (MHWFAC) we expect this key individual to be involved in a portfolio with a minimum of three simultaneous trials in different subject areas and varied sponsors while contributing to a positive workplace culture.

Coordinator experience and mastery of all job duties from the CRC Associate position on the Michigan Medicine CRC Career Ladder is required.

The successful candidate be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed this individual will apply their skills to a broad range of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This individual will be expected to perform quality checks of their work, will know how to identify appropriate resources and are able to discern when to escalate issues needing additional intervention. 

The characteristic duties and responsibilities of this 100% position (40 hours/week) may evolve over time to match changing needs and priorities and may include work on other research studies and Clinical Trials. This position receives direct supervision and reports directly to Project Manager.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Responsibilities*

RESEARCH TASKS (75%) INCLUDE

Functions as liaison between participants, investigators, sponsors and other interested parties such as members of Research Pharmacy and MCRUPerforming regulatory activities in collaboration with sponsors, local and central IRB?s, the CTSU and associated entitiesRecruiting potential study subjects, assisting in eligibility determinationPerforming data entry related to participant screening & study visitsMonitoring and treating subject reactions together with study investigators during food challenges and in-clinic dosing of immunotherapy product.Maintenance of accurate source documentation and essential documentsTracking and maintaining data and sample collection and resolving data/sample queriesCollect and record participants study-related data Collect, process, label, store, and ship bio-specimens from participants for clinical studiesWorking with lab staff to ensure biospecimens are handled appropriately and safelyAssist with adherence to study budgets and financial reconciliation

ADMINISTRATIVE TASKS (25%) INCLUDE

Managing purchase of supplies, coordinating purchases with research and administrative staff as neededMaintaining equipment and software for participant data collectionRequired Qualifications*Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent.  Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire.  (Please review eligibility criteria from SoCRA or ACRP prior to applying.)Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)  Basic Life Support (BLS) certificationAbility to move equipment up to 25lbsExceptional organizational, interpersonal and communication skills (verbal and written)Comfort dealing with children and adults having a severe allergic reaction, or willingness to learnReliable transportation to travel to multiple work locationsDesired Qualifications*Medical assistant or certified nursing assistant certification/licensurePhlebotomy knowledge and knowledge of lab proceduresAbility to effectively communicate with staff and faculty of all levelsAn understanding of medical terminologyExperience working in a complex health care settingExperience working with families, ideally with food allergiesPrevious experience with EPIC and electronic data capture systemsKnowledge of university research policies and proceduresModes 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

This is a term-limited appointment ending after approximately one year with the possibility of renewal based on need, available funding and candidate performance. At the end of the stated term, the appointment will terminate, and you will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.

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 Statement

The University of Michigan is an equal employment opportunity employer.