Clinical Research Coord Assoc - Term Limited

University Of Michigan; Ann Arbor (MI); Hybrid; USD 50,000 - 70,000; Full time

Job summary

The University of Michigan seeks a Clinical Research Coordinator for the Mary H. Weiser Food Allergy Center. This role involves managing clinical trials, ensuring compliance, and maintaining participant data. The ideal candidate will have strong organizational skills and a background in health sciences.

Qualifications

• Certification as CCRC or CCRP required within six months of hire.
• Comfort dealing with allergic reactions or willingness to learn.

Responsibilities

• Liaison between participants, investigators, and sponsors.
• Performing regulatory activities and recruiting study subjects.
• Collecting and processing bio-specimens from participants.

Skills

Organizational Skills

Interpersonal Skills

Communication Skills

Education

Bachelor's degree in Health Science

Tools

EPIC

Job description

Clinical Research Coord Assoc - Term Limited

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.

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 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

Required 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.)
• Exceptional organizational, interpersonal and communication skills (verbal and written)
• Comfort dealing with children and adults having a severe allergic reaction, or willingness to learn
• Reliable transportation to travel to multiple work locations

Desired Qualifications*

• Medical assistant or certified nursing assistant certification/licensure
• Phlebotomy knowledge and knowledge of lab procedures
• Ability to effectively communicate with staff and faculty of all levels
• An understanding of medical terminology
• 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

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

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.

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 maybegin as early as the eighth day after posting.Thisopening 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.

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