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 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
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
- Working 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 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
