Clinical Research Coordinator Lead

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 .

Michigan Medicine is comprised of over 30, 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*

Expert level 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

Specific duties will include :

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 independently oversee common project activities, establish administrative protocols, budget assessments, implementation methods, and track and maintain IT resources.
• Independently draft reports, organize meetings with detailed agendas and minutes, and manage project logistics including Community Advisory Board (CAB), Steering Comm.

SC), internal and external advisory board (IAB / EAB) meetings, and organizing of events for dissemination of research findings.

• Proactive and meticulous oversight of forms, databases, regulatory files, and creating SOPs.
• Responsible for financial and staff management to meet project goals and will have the autonomy to make significant decisions in line with project objectives.
• Maintain minutes and Action plans from standing meetings
• Other activities as needed for the overall PEACE grant

Clinical Research Coordinator Responsibilities

• As an integral part of the PEACE study team, works closely with Principal Investigators, program manager, and various teams to shape and execute the study's overarching strategy.
• Organize and facilitate all aspects of standing recurrent meetings including MPI meetings, monthly Steering Committee Meetings, and Project PI meetings
• Plan and execute national annual PEACE meeting.
• Be the primary administrative contact for the program
• Responsibilities also include handling start-up, active, and closing phases of the project and overseeing inventory.

Research Regulatory Coordinator Responsibilities

• 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.
• 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.
• Maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to research compliance.

Research Data Coordinator Responsibilities

• Create and manage databases, including designing logic, drafting Case Report Forms (CRFs), identifying data elements, and developing database in REDCap.
• Additionally, responsible for establishing processes, tools, and training to ensure data is captured accurately and consistently in line with ALCOA-C principles within the REDCap system.
• 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.

Training / Community Engagement / Other

• Facilitate effective communication between community and academic partners.
• Help initiate PEACE Pilot grant funding applications. Facilitate various aspects of the pilot grant process, including online application management, submission coordination, review and selection procedures, and compiling reports from pilot grantees.
• Work with Communications Specialist to maintain database of word and graphic based products including flyers, social media messages, etc.
• Assist in supporting key personnel in project documentation and manuscript preparation; associated tasks with the Steering Committee's efforts and in align with NIH publication requirements.
• Provides mentorship of other clinical research staff; maintains certification.
• 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.

Supervision Received :

This position reports directly to the Research Operations Senior Manager for Women's Health and Reproductive Disparities Collaborative.

Supervision Exercised :

Possibly provide Functional supervision, in a limited capacity, such as training of staff in titles within the CRC Career Ladder.

Required Qualifications*

• Bachelor's or Master's degree in Research Administration, Public Health, Social Work, Psychology, Business, Education, Social Sciences, or related field
• Certification is required through Association of Clinical Research Professionals (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 orprior to applying.)

• Medical or public health research background
• Fluency in Microsoft Software i.e. Word, PowerPoint, Excel, etc.
• At least 10 years of experience as a program or research coordinator / manager
• Fluency in REDCap database building and management skills required.
• Demonstrable experience in managing multidisciplinary and multicultural teams.
• A commitment to diversity, equity, and inclusion, and cultural sensitivity.
• Demonstrated high degree of initiative and resourcefulness
• Able to work independently and work collaboratively with diverse groups across the research continuum (e.g., faculty, patients, community members, frontline providers, research managers, policymakers, research administration, and administrative staff)
• Experience coordinating multisite research projects, including budgets and workplans.
• Knowledge of and experience with IRB processes, submitting research studies to the University of Michigan's Institutional Review Board (IRBMed or IRB-HSBS).
• Exceptional attention to detail, and excellent written and oral communication skills
• Excellent organizational, leadership, and decision-making skills.
• Willingness to travel throughout Michigan and nationally to conferences, as needed
• Proficiency in -and research management software including reference management and file sharing software (e.g., Dropbox, Google Drive, Trello, Zotero), communication and meeting management (e.

g., Zoom, Teams, Slack); and presentation software (e.g., Canva, etc.)

Level Specific Requirements :

LEAD :

• CRC Governance Committee review and approval
• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
• Minimum 5+ years of directly related experience in clinical research and clinical trials is necessary

Desired Qualifications*

• Masters or PhD
• Experience using social media platforms
• Survey research experience and skills; Mixed-methods skills including qualitative and quantitative research methods
• Qualtrics experience
• Experience in mixed-methods or qualitative research
• Experience with data visualization and synthesis
• Ability to manage responsibilities and manage time effectively to meet deadlines.
• Demonstrate excellent problem-solving, analytical, and critical thinking skills
• Ability to set priorities, handle multiple assignments and deadlines and display excellent judgment while operating in a flexible and professional manner;

strong ability to multitask while remaining focused is essential.

• Demonstrated ability to work independently with minimal supervision. and adapt to the needs of the program
• Demonstrated ability to work with diverse teams of people in a diplomatic, inclusive, collaborative and effective manner;

Ability to effectively lead diverse work teams

• Working knowledge of applicable University policies and procedures preferred
• Ability to make independent decisions while working toward a shared strategic vision

Work Locations

This position is hybrid, with 2-3 days / week onsite work in Ann Arbor, MI *required* and / or community-based work throughout Michigan.

There will be some 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