Clinical Research Coord Assoc

How to Apply

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

This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers. Help discover them.

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 escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

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.

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 30,000 employees 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

Responsibilities*

Characteristic Duties And 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

This position reports directly to a CRC-Lead, CRC-Project Manager, or a unit Administrator.

Duties

Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role. The clinical research coordinator hired for this posting will specialize in Regulatory. Examples of duties a successful candidate in this role will perform:

Clinical Research Coordinator - Associate

• 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.
• Collaborates with MIAP for INDs and IDEs.
• 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 all 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.

This position reports directly to a CRC-Lead, CRC-Project Manager, or a unit Administrator, Director.

Clinical Research Coordinator - Technician

This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Assistant position is required.

• May complete new eResearch applications.
• May maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• May gather participant approval via informed consent.
• Prepares and participates in internal and external audits.
• Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
• Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately.

Clinical Research Coordinator - Assistant

This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.

• May work with regulatory support to collect essential documents and maintain regulatory binder (CVs), MD licenses, lab certifications, IRB rosters, lab norms, etc.)
• Assists with AEs and SAEs, ORIOS reporting; Uses proper documentation techniques as outlined in the ICH-GCP guidelines.
• Demonstrates understanding of the clinical research objectives associated with the program.
• May assist research coordinator in conduct of SIV; attends SIV.
• May assist in and attends monitor visits and or audits.

Required Qualifications*

Clinical Research Coordinator - Associate

• 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)
• 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.
• 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.
  

Clinical Research Coordinator - Assistant

• High School Diploma or GED

Desired Qualifications*

Clinical Research Coordinator - Associate

• 4+ years of direct related experience.

Clinical Research Coordinator - Technician

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable. 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.

Clinical Research Coordinator - Assistant

• Associate Degree in Health Science or an equivalent combination of related education and experience is desirable. 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.

Work Schedule

Monday through Friday, core business hours. Occasionally evening or weekend work to meet deadlines or support patient care.

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.

Underfill Statement

This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates' qualifications.

Additional Information

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

Background Screening

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 may begin as early as the eighth day after posting. This opening 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 employment opportunity employer.