Clinical Research Coord Assoc

University Of Michigan; Ann Arbor (MI); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Excellent medical, dental and vision

2:1 retirement match

Job summary

University of Michigan's REMEDY team seeks a Clinical Research Coordinator with experience managing surgical clinical trials. The role supports multi-center, device, and outcomes research, requiring independence, attention to detail, and proficient use of e-clinical tools.

Collaboration with investigators across departments and external partners is expected. The position emphasizes adherence to GCP, data integrity, and regulatory compliance, with opportunities to advance within the Michigan

Qualifications

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
• Certification is required through ACRP or SoCRA with eligibility to register or take the exam within six months of hire.
• An understanding of medical terminology and experience in a large complex health care setting are desirable.

Responsibilities

• Understand protocol elements and requirements.
• Execute study procedures with minimal supervision.
• Triages routine participant concerns and issues appropriately.
• Coordinate scheduling, preparation, and attendance at study-related meetings.
• Document data in accordance with ALCOA-C principles and study data management plans.
• Identify and report adverse events (AEs), Serious Adverse Events (SAEs), and other reportable information.
• Maintain essential regulatory documents per GCP guidelines and related policies.
• Serve as primary contact for the study team and supervise none.

Education

Bachelor's degree in Health Science or related

Job description

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.

Job Summary

The REMEDY team at the University of Michigan (UM) manages the vast portfolio of surgical clinical trials for the Department of Cardiac Surgery. The team consists of varying levels of coordinators dedicated to advancing healthcare to improve outcomes for patients. Our collaborators include investigators from other departments within UM, industries, and Universities. We specialize in multi-center, including international, device trials as well as outcomes research, drug trials, and investigator-initiated studies. As we continue to expand our portfolio, we are looking for detail orientated, highly motivated, compassionate individuals to join our team.

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 escape 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:

Scientific Concepts and Research Design

Ethical Participant Safety Considerations

Investigational Products Development and Regulation

Clinical Study Operations (GCPs)

Study and Site Management

Data Management and Informatics

Leadership and Professionalism

Communication and Teamwork

Responsibilities will include, but are not limited to:

Understanding of protocol elements/requirements

Executing study procedures

Anticipating and mitigating the potential for protocol non-compliance

Accurate implementation of protocol procedures

Describing and performing routine study management activities

Performing study procedures with minimal supervision

Triaging routine participant concerns and issues appropriately

Scheduling, assisting with preparation, and attending study-related meetings (e.g. study initiation meetings, audits, monitoring visits, or community-based organizational meetings)

Participating in regular study meetings

Properly completing payment forms and pays participants accordingly

Serving as primary point of contact for study and/or a study team

Documenting data in accordance with ALCOA-C principles and/or the study data management plan

Appropriately identifying and reporting adverse events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs)

Maintaining essential documents as outlined in the GCP guidelines, or other relevant guidelines.

Other related duties as assigned.

Supervision Received: This position reports directly to the Clinical Trial Lead for the Department of Cardiac Surgery.

Supervision Exercised: None.

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.)

An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world?s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

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 .

Work Schedule

Hours/Week: 40 hours

Shift/Hours/Days: Days, occasional evening and weekends, on call

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 any time after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.