Clin Res Project Manager

Clinical Research Project Manager

This position will serve as a Clinical Research Project Manager in the Oncology Clinical Trial Support Unit (O-CTSU) - providing operational and administrative support for the clinical research Quality Assurance Review Core 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 on the Michigan Medicine CRC Career Ladder is required. This position has oversight for clinical research projects and has responsibility for ensuring that they are completed within specifications. This position establishes operational objectives and assignments and defines and manages project resource needs including project staff. Employees in this classification typically analyze, compare, and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision-making authority are predominantly performed independently affecting business operations to a substantial degree.

Responsibilities*

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 Quality Assurance Review Core. This position may also contribute to the development of protocols with varying levels of complexity to enhance the administration and execution of clinical trials.
• Runs core meetings, establishes meeting agendas, records meeting minutes, and manages outcomes. Provides administrative supervision to a team of 4. Maintains accurate tracking systems of core activities, audit files, corrective and preventative action (CAPA) plans, etc. Acts as a liaison between the core, investigators, research teams, etc. to get questions answered and issues resolved. May provide guidance and functional oversight to study teams with regard to issued CAPAs. Independently interacts and provides routine reports to the Medical Director of Quality Assurance (MDQA).
• Ensures all clinical trials receive appropriate auditing compliant with institutional requirements based on study sponsor, intervention(s), and risk to participants. Maintains roster of eligible physician investigators to serve as chart auditors and manages auditing assignments.
• Oversees audit documentation for quality assurance. Reviews audit findings for completion and accuracy and ensures timely distribution of audit reports. Ensures investigator responses to audit findings are timely and complete and assists the MDQA to ensure that audit findings requiring a response and/or CAPA plan are adequately addressed. Ensures timely reporting of audit findings and investigator responses to the DSMC and facilitates completion of for cause audits at the request of the DSMC.
• Assists the MDQA and Associate Director of Compliance in the strategic direction and implementation planning of core activities. Assists the Associate Director of Compliance with FDA audits and other external audits as needed. Assist with reporting requirements to UM's Office of Research Compliance Review (ORCR) per the agreed upon MOU.
• Contributes to the development of processes, tools, and trainings to ensure accurate data collection at the site level. Performs at the highest level of data management working with the core's statisticians, including but not limited to: 1) the establishment and oversight of the audit design data structures and annual review, 2) facilitating an independent interim analysis for the DSMC, and 3) facilitating review of the final dataset for ClinicalTrials.gov submission.
• Provides training and mentorship of other clinical research staff on a range of policies, regulations and best practices. Works routinely with regulatory, data, and clinic education coordinators in developing ongoing (re) training plans as a feedback loop from audit trends.

Required Qualifications*

Clinical Research Project Manager

• Master'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 the date of hire, and the certification must be completed or passed etc. within six months of date of hire.
• Minimum 6 years 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 - Lead

• 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 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.

Desired Qualifications*

Clinical Research Project Manager

• Prior experience providing administrative supervision of a team
• Prior experience auditing and/or monitoring clinical trials
• Project Management certification
• 10+ years of direct related experience

Clinical Research Coordinator - Lead

• Prior experience providing functional supervision of a team
• Prior experience auditing and/or monitoring clinical trials
• 9+ years of direct related experience

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

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

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

Underfill Statement

This position may be underfilled at the CRC-Lead title based on selected candidates' qualifications.

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