JOB SUMMARY

The Department of Neurology is seeking a Clinical Research Coordinator (CRC) to lead an NIH-funded clinical trial focused on Parkinson disease at Michigan Medicine. The CRC will schedule and conduct participant research evaluations, oversee data entry and regulatory compliance, and will partner with colleagues in a multidisciplinary study team including data management, Neuropsychology, Neurology, Radiology, Pharmacy, and other services. The CRC will also conduct chart-based pre-screening, phone screening and phone follow-up visits. The CRC will coordinate with Research Pharmacy for the shipping and return of study drug. The CRC will communicate regularly with members of the study team including the co-principal investigators and other study coordinators work on this project.
This position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the Clinical Research Technician position is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types 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 position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

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.
• 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.)

• Clinical Coordinator Responsibilities ex. ? Performs non-GCP related study management activities; Performs study procedures with minimal supervision; Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits; Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.)
• Data Coordinator Responsibilities ex. ? Demonstrates the ability to document data in accordance with ALCOA-C principles; Completes complex data collection during study visits; Demonstrates ability to resolve data queries
• Regulatory Coordinator Responsibilities ex. ? Form completion and reporting to external governing bodies such as the FDA; Demonstrating an understanding of the elements of subject safety, related documentation, and reporting; Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks
• Administrative Responsibilities ex. ? Provide other administrative support for study activity including management of subject reimbursement and payments
• Training ex. ? Participates in trainings specifically for certification as a Clinical Research Professional