MADC Clinical Research Coordinator Associate

Clinical Research Coordinator Associate

The Michigan Alzheimer’s Disease Center (MADC) is an NIH-funded research center focused on conducting and supporting Alzheimer’s disease and related dementia research. A key aim of the center’s research is to work with communities to address disparities in Alzheimer’s disease and related dementias. The center also spans beyond research by promoting state-of-the-art care and wellness for individuals and families affected by dementia and increasing dementia awareness through education and outreach across the state.

The MADC is seeking a full-time Clinical Research Coordinator Associate to join its research team. The work location is onsite at the Michigan Alzheimer’s Disease Center in Ann Arbor and the Michigan Clinical Research Unit (MCRU) at Michigan Medicine. Hours are Monday to Friday, 8 am to 5 pm.

We are seeking an experienced, positive, highly motivated, organized person with excellent multi-tasking ability and record-keeping skills to work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of research studies. The candidate will be expected to work closely with faculty and staff and be able to administer standardized and computer-based cognitive, behavioral, and motor assessments to research participants and score neuropsychological examinations. The candidate will be able to operate in a semi-independent manner to assist in clinical research and related projects. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities.

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.

Responsibilities*

Independent knowledge, skills, and abilities within all 8 competency domains is expected

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

The Clinical Research Coordinator hired for this posting will specialize in clinical trial coordination, including data management, regulatory, and research clinic coordination duties. Examples of duties a successful candidate in this role will perform are as follows:

• Administer paper/pencil and computerized neuropsychological examinations and surveys to research participants at the MADC and at the Michigan Clinical Research Unit (MCRU) for supported clinical trials of the MADC
• Score neuropsychological evaluations
• Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures
• Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance
• Describes protocol structure and explains how to interpret study requirements to ensure study compliance
• Demonstrates accurate implementation of protocol procedures
• Explains and performs non-GCP related study management activities
• Performs study procedures with minimal supervision
• Triages simple subject concerns and issues appropriately
• Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits

• Completes complex data collection during study visits
• Document all relevant data used in multiple research studies
• Enter electronic data into a secure electronic data capture system database
• Demonstrates the ability to document data in accordance with all required protocols, ensuring all study-related documentation is completed accurately
• Demonstrates ability to resolve data queries

• Explains and performs study operational activities in compliance with Good Clinical Practice (GCP)
• Explains proper documentation techniques as outlined in the ICH-GCP guidelines
• Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them
• Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT
• Demonstrates understanding of University and Federal guidelines in order to assist with Investigator Initiated studies
• Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks
• Demonstrates proficiency in eResearch applications and submissions, such as continuing renewals and amendments
• Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines
• Maintenance of updated regulatory documentation
• Explain the investigational products development process and identify key regulations to control these processes

• May assist with creating posters, abstracts, and articles
• Participates in regular study meetings. Properly completes payment forms and pays participants accordingly
• Work collaboratively with MADC, Neurology, and Neuropsychology clinical trials teams
• Perform general office and administrative duties as assigned

• All training requirements of previous level
• PEERRS, HIPAA, CITI GCP
• eRPM Regulatory training
• Attends and participates in all training assigned to this level

SUPERVISION RECEIVED

This position reports directly to a Center Administrator

SUPERVISION EXERCISED

None

Required Qualifications*

• Clinical Research Coordinator - Associate
• Bachelor's Degree in Health Science or equivalent in combined education and clinical research experience.
• 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)
• 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 qualifying experience prior to applying.
• Clinical Research Coordinator - Technician
• Associate Degree in Health Science or an equivalent combination of related education and experience is necessary.
• ONE of the following:
• Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
• An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
• Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.

Desired Qualifications*

• Experience working with older adults with/without memory loss
• Experience with electronic data entry in REDCap or another platform
• A working knowledge of medical terminology and assessment of laboratory values
• PEERRS or CITI Program certified
• Knowledge of Michigan Medicine 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.

U-M EEO Statement

The University of Michigan is an equal employment opportunity employer.