Clinical Research Coordinator LeadExtended Site MaintenanceWe are performing updates and maintenance to our applicant experience. As a result, the site will be unavailable Saturday, July 27th at 9pm EST through Sunday, July 28th at 7:30am EST. During this outage period, applications for job postings can not be submitted.Apply NowHow to ApplyA 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.SummaryAn exceptional opportunity is available for a highly motivated and experienced Clinical Research Coordinator Project Manager/Lead to oversee the clinical research activities within the Obstetrics and Gynecology Department with the PEACE Project Grant. A $7.8 million grant from the National Institutes of Health will fund a joint research effort entitled Partnering for Equity: An Academic and Community Alliance to Eliminate Disparities throughout the Fibroid Experience (PEACE) by researchers from multiple institutions.We are looking for a candidate who can work independently, and in collaboration with multiple project PIs and community members with guidance required in only the most complex situations. The candidate should be able to set up and streamline study operations, maximize efficiency, and ensure the successful completion of clinical studies.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.CRC STATEMENT: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-Lead position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC 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, demonstrate, develop, guide, and support.Mission StatementMichigan 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
ResponsibilitiesExpert 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 ( 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 prior 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 LocationsThis 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.Additional InformationThe 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 ScreeningMichigan 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 DeadlineJob 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 StatementThe University of Michigan is an equal opportunity/affirmative action employer.Job DetailJob Opening ID252107Working TitleClinical Research Coordinator LeadJob TitleClinical Research Coord LeadWork LocationAnn Arbor CampusAnn Arbor, MIFull/Part TimeFull-TimeRegular/TemporaryRegularFLSA StatusExemptOrganizational GroupMedical SchoolDepartmentMM Obstetrics & Gynecology DptPosting Begin/End Date7/25/2024 - 8/24/2024Career InterestResearchApply Now
