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.

This position will serve as a Clinical Research Coordinator Senior in the Oncology Clinical Trial Support Unit (O-CTSU) - providing operational and administrative support for the clinical research oversight committees and providing protocol development 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 175 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 will provide study oversight of multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Intermediate position on the Michigan Medicine CRC Career Ladder is required. This position gives back to the institution through mentoring others on study regulations and best practices and participating in training and development of junior clinical research professionals. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and mentor study team members on internal compliance requirements and NCI guidelines. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This level of CRC develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. This position continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, develop, evaluate, guide, mentor, and support.

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.

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

Characteristic Duties and 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

This position reports directly to a unit Administrator.

As a member of a compliance team, this position independently provides operational and administrative support for the clinical research oversight committees. This position may also contribute to the development of protocols with varying levels of complexity to enhance the administration and execution of clinical trials.

• Oversees regulatory documentation for quality assurance. Reviews new study applications and amendment submissions for completion and accuracy.
• Ensures protocols contain the minimum standard requirements for committee review, including plans for monitoring site compliance of subject safety reporting.
• Establishes meeting agendas, records meeting minutes, and provides committee outcome notifications. Develops and maintains accurate tracking systems for committee activities and audit files.
• Acts as a liaison between the committee, investigators, research teams, etc. to get questions answered and issues resolved.
• Assists investigators with the development and maintenance of investigator-initiated cancer clinical research protocols. Collaborates with investigators and institutional partners to produce high quality protocol documents meeting federal regulations and institutional standards that also reduce ambiguity and provide clarity of execution by other CRCs. Maintains and updates master protocol templates for studies clinically coordinated under Rogel Cancer Center.

• Provides supportive training, group mentorship, and individual coaching of novice regulatory staff supporting cancer-related studies on internal compliance requirements and NCI guidelines.

   

Clinical Research Coordinator - Senior

• Mastery of all job duties from the Clinical Research Intermediate position is required.
• Bachelor's degree in health science or an equivalent combination of related education and 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 the date of hire, and the certification must be completed or passed etc. within six months of date of hire.
• Minimum 5 years of directly related experience in clinical research compliance oversight and/or clinical research and clinical trials is necessary.
• Knowledge of research regulations and best practices.
• Excellent communication, interpersonal, and organizational skills.
• Ability to work independently, prioritizing multiple tasks to meet deadlines.

Clinical Research Coordinator - Intermediate

• Mastery of all job duties from the Clinical Research Associate position is required.
• Bachelor's degree in health science or an equivalent combination of related education and 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 the date of hire, and the certification must be completed or passed etc. within six months of date of hire.
• Minimum 3 years directly related experience in clinical research and clinical trials is necessary.
• Knowledge of research regulations and best practices.
• Excellent communication, interpersonal, and organizational skills.

• Ability to work independently, prioritizing multiple tasks to meet deadlines.

   

Clinical Research Coordinator - Senior

• 9+ years of direct related experience.

Clinical Research Coordinator - Intermediate

• 6+ years of direct related experience.

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

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.

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

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.

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 anytime after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.