Clinical Research Coordinator Associate

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.

This clinical research coordinator (CRC) 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 CRC-Technician position on the Michigan Medicine CRC Career Ladder 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 elevate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person.

Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.

Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI.

Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). May also assist with the consent processes.

Maintains and coordinates data collection information required for each study that may also include developing CRF's (case report form) or data collection tools.

Assists in developing and implementing research studies, may include writing clinical research protocols.

Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.

May assist the PI on the fiscal management of the trial including budget preparation.

Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.

May perform research billing activities, as needed, based on size of department (including linking patient calendars).

Coordinates data management and collection for national (larger/more complex) research studies or multiple research studies at a given time.

Serves as primary liaison/lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.

Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents.

Provides in-service training to all study team members and communicates to involved groups.

Reviews research study protocols to ensure feasibility requirements of the study.

Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.

Enters…