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.
The Mary H. Weiser Food Allergy Center is seeking a highly motivated clinical research Intermediate for multiple clinical research studies, ranging from moderate to complex, investigating the development of new treatment modalities for food allergies.
As a clinical research Intermediate 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.
The successful candidate will 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 will be 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 additional research studies. Coordinator experience and mastery of all job duties from the CRC Intermediate position on the Michigan Medicine CRC Career Ladder is required. This position receives direct supervision and reports directly to the Project Manager.
RESEARCH TASKS (75%) INCLUDE
- Functions as liaison between participants, investigators, sponsors and other interested parties such as members of Research Pharmacy and MCRU.
- Performing regulatory activities in collaboration with sponsors, local and central IRB?s, the CTSU and associated entities.
- Recruiting potential study subjects, assisting in eligibility determination.
- Performing data entry related to participant screening & study visits.
- Monitoring 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 documents.
- Tracking and maintaining data and sample collection and resolving data/sample queries.
- Collect and record participants' study-related data.
- Collect, process, label, store, and ship bio-specimens from participants for clinical studies.
- Work with lab staff to ensure biospecimens are handled appropriately and safely.
- Assist with adherence to study budgets and financial reconciliation.
ADMINISTRATIVE TASKS (25%) INCLUDE
- Managing purchase of supplies, coordinating purchases with research and administrative staff as needed.
- Maintaining equipment and software for participant data collection.
- Bachelor's degree.
- Minimum 3 years of directly related experience in clinical research and clinical trials. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying)
- Certification is required through the 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 Professional (CCRP) or equivalent. Candidates must be eligible to register or take the exam at the date of hire, and the certification must be completed or passed, etc., within six months of the date of hire. (Please review eligibility criteria from SoCRA or ACRP)
- Basic Life Support (BLS) certification.
- Ability to move equipment up to 25lbs.
- Exceptional organizational, interpersonal and communication skills (verbal and written).
- Comfort dealing with children and adults having a severe allergic reaction, or willingness to learn.
- Experience with data collection, data entry, and maintaining data confidentiality.
- Reliable transportation to travel to multiple work locations.
- Working knowledge of Good Clinical Practice (GCP) and human subjects research procedures.
- Medical assistant or certified nursing assistant certification/licensure.
- Qualified/trained to perform venipuncture (blood draws).
- Ability to effectively communicate with staff and faculty of all levels.
- Experience working in a complex health care setting.
- Experience working with families, ideally with food allergies.
- Previous experience with EPIC and electronic data capture systems.
- Knowledge of university research policies and procedures.
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.
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.
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.
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 Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including
