Clinical Research Coord Senior

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

An exceptional opportunity is available for a highly motivated and experienced Community Engagement and Research Coordinator to support community-engaged research projects with the onWHARD (Women's Health And Reproductive Disparities) team within the Obstetrics and Gynecology Department. The Research and Stakeholder Advisory Group coordinator will support clinical research community engagement needs on grants from the National Institutes of Health (NIH), Patient Centered Outcomes Research Institute (PCORI), and other projects. They will also support with study coordination for the PCORI (and other studies) and support with recruitment, screening, consenting, data collection, regulatory submissions, and other study related activities.  Alongside, this individual will oversee all Stakeholder Advisory Group (SAG) and its Leadership activities needed to support project contributors by playing a pivotal role in managing the SAG and collaborating with the Steering Committee (SC), collecting and coordinating contributor data and feedback, providing educational outreach, participating in site visits, and support the development of a robust CE plan.  This is a unique opportunity to contribute to meaningful research while working with a large and diverse team.

We are looking for a candidate who can work independently, and in collaboration with multiple project PIs and community members, including patients, family members, advocates, etc., with guidance required in only the most complex situations. The successful candidate will be experienced, positive, highly motivated, organized, and autonomous individual with excellent communication and multi-tasking skills to join our growing research team. This position will work closely with principal investigators and other research team members to accurately and efficiently carry out a range of tasks and provide study coordination for multiple research studies of high complexity across research sites.  The role will also provide functional supervision for one or more junior clinical research team members. The candidate should be able to gather and understand internal or external issues and recommend solutions/best practices and solve complex problems and take a broad perspective to identify solutions. They may lead functional teams as well. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities.

At onWHARD we celebrate diversity and are committed to creating an inclusive environment for all team members. We know that our differences fuel innovation and excellence and understand that diversity and inclusion are critical to our success. We welcome applicants from all backgrounds, cultures, orientations, and experiences.  We are committed to promoting health equity through community engagement and participatory research approaches. We seek candidates who share our dedication to diversity, equity, inclusion, and anti-racism.

This clinical research coordinator (CRC) position may provide study coordination for 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, including experience with various committees at the University. This position gives back to the institution through mentoring others on study management 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 in the implementation of study related activities. 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.

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*

Contribute to the development of process and tools in 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

Clinical Research Coordinator Responsibilities

• Be the primary administrative contact for the project for Univ. of Michigan.
• As an integral part of the study team, works closely with both site Principal Investigator and National PIs, program manager, and various teams to shape and execute the study's overarching strategy.
• Organize and facilitate all aspects of standing recurrent meetings including PI meetings, monthly SAG Meetings, and Project PI meetings.
• Handling start-up, active, and closing phases of the project and overseeing inventory. Handle, support, oversee the submission of IRB applications for all projects, create study SOPs, and ensure compliance with all study-related submissions and quality assurance.
• Create and manage databases, including designing logic, drafting Case Report Forms (CRFs), identifying data elements, and developing database in REDCap as needed.
• Support the collection of qualitative and quantitative data from various community engagement tools like interviews, surveys, and focus groups; assist with data analysis by providing context and meaning.
• Responsible for establishing processes, tools, and training to ensure data is captured accurately.
• Candidate will work with other program staff, developing and presenting educational materials, to ensure uniformity of review and compliance with standard operating procedures and applicable federal and state regulations.
• Coordinate projects with academic, research, community, local government, and regional partners to strategize participant recruitment from various clinics and implement Women?s Health education. Identify ways to recruit underrepresented populations in research projects and conduct qualitative interviews per protocol.
• Monitor and address site compliance for subject safety, develop methods to improve participant protection, and create tools to enhance site adherence to regulations for the safe development of investigational products.
• Complete and submit IRB applications, amendments, and manage reporting requirements. Maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to research compliance.
• Proactive and meticulous oversight of forms, databases, regulatory files, and creating SOPs.
• Functional management of staff and students as needed to meet project goals and will have the autonomy to make significant decisions in line with project objectives.

Community Engagement / SAG Coordination

• Act as the main point of contact for SAG members, addressing issues and tracking resolutions.
• Establish protocols for managing community engagement based on Community-based Participatory Research (CBPR) best practices.
• Schedule and coordinate SAG meetings, developing agendas in consultation with the project director.  Provide logistical support including scheduling location, taking minutes and distributing relevant documentation.
• Draft plans to educate SAG members, other stakeholders, community members, and other contributors on relevant health topics, research purpose, interventions, and other areas driven by community needs. 
• Oversee activities such as meet-and-greets, listening sessions, and formal updates. Engage with research and community participants, patient advocates, and other professionals and track misalignments between SAG, SC priorities and project research needs.
• Plan, develop, and implement processes for the management and support of SAG. Ensure SAG members become informed and involved in all levels of the research project as appropriate and needed.
• Create and maintain templates, systems, and procedures for collecting contributor data. Analyze and process feedback from community, SAG, and others and actively communicate to the PIs / Manager.
• Site Visits: Support/plan/facilitate site visits, coordinating with research and administrative staff to meet project needs.  Coordinate interviews, program evaluations, strategic plans, needs assessment, as needed.
• Actively engage with other co-PIs and counterparts in other institutions to collaborate on the project. Facilitate and communicate actively any identified issues to research team/manager.
• Maintain thorough documentation of engagement activities and assist in the preparation of progress reports for various audiences including internal and external stakeholders/funders. Communicate issues immediately and identify 
• Event Planning: In coordination with the manager, project research coordinator, communications specialist, and research team, support the development, execution, engagement, data dissemination, of community events tailored to specific community groups for projects within onWHARD.

Project Management and Research Administration Responsibilities

• Will serve as the central administrative coordinator, facilitating communication across research teams, sponsors, and other stakeholders across the different sites.
• Will support common project activities:  establishing administrative protocols, budget assessments, implementation methods, and track and maintain IT resources.
• Independently draft reports, organize meetings with detailed agendas and minutes.

Required Qualifications*

• CRC Governance Committee review and approval
• 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 orACRP prior to applying.)
• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary.  (Please review SoCRA?s Definition of a Clinical Research Professionalfor qualifying experience prior to applying.)  

• Experience with relationship and coalition building. Familiarity with community-engaged research is a plus.
• Experience and ability communicate information in a culturally appropriate, respectful manner to a variety of audiences and diverse populations.
• Experience in public health, community health, or health equity initiatives.
• Understanding and proven ability to work with minority communities and those experiencing health inequity. Must be culturally aware and demonstrate cultural humility.
• Experience in research, qualitative data coding and analysis, quantitative data capture and analysis.
• Fluency in Microsoft Office applications, ideally with experience in design and/or data visualization tools such as Canva, Publisher, Tableau.
• Skills:
  • Excellent communication skills, both verbal and written.
  • Proactive and engaging, with strong listening skills.
  • Experience in organizing and facilitating focus groups, interviews, and surveys.
  • Database management and familiarity with social media and podcasting for health messaging. 

CRC Intermediate Requirements: 

• 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 orACRP prior to applying.)
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary.  (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)  

Desired Qualifications*

• 9+ years of direct related experience
  
  
• Master's degree in public health, community health education, or a related field.
• Relevant certifications like Community Health Education Specialist (CHES), Cert. in Public Participation (CPAP), Community Research & Action (CRA), or Certified Clinical Research Professional (CCRP) etc. are desirable.

CRC Intermediate Desired Qualifications: 

• 6+ years of direct related experience

Work Schedule

This position will require work hours outside the typical business hours to attend community events, SAG meetings, and other engagements including some evenings and weekends.

Work Locations

• This is a hybrid position. The CRC is expected to be onsite at least 2-3 days per week. 
• Ability to travel and participate in site visits and community events is integral and essential to this role. As needed, they could be required to visit sites and/or attend CE activities at various community sites across the State of Michigan, primarily in SE Michigan.  Occasional travel to national meetings.

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 a lower classification depending on the qualifications of the selected candidate.

Additional Information

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

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 recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of 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 anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.