Clinical Research Coord Inter

Clinical Research Coord InterApply 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.Job SummaryThis 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-Associate 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.This position is currently aiming to engage the clinical research coordinator in clinical trials evaluating novel treatments for diabetes, and reducing complications from diabetes.The focus of the research will be on the following clinical trials and research studies:

PRECIDENTD PREvention of CardIovascular and DiabEtic KidNey Disease in Type 2 Diabetes ? a PCORI funded, Phase IV, large scale Pragmatic Clinical Trial comparing the effect of GLP-1 RA (or dual GIP/GLP-1 RA) to SGLT-2i agents to prevent the risk of cardiovascular disease and diabetic kidney disease in patients with Type 2 Diabetes.

A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Pivotal Study to Assess the Efficacy of Revita? Duodenal Mucosal Resurfacing (DMR) on Body Weight Maintenance in Participants with Obesity and Who Have Achieved at Least 15% Weight Loss on Tirzepatide Obesity Pharmacotherapy (REMAIN-1)

Type 1 Diabetes Exchange (T1DX-QI)

Additional future opportunities may be available in TrialNet, the Teplizumab Registry, and the Long-Term Study of MODY-Monogenic Diabetes (University of Michigan?s MODY Registry) if thes are of interest to the applicant.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

ResponsibilitiesContribute to the development of process and tools in 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

Duties and Responsibilities:Clinical Coordinator Responsibilities:

Performs study procedures with accuracy

Demonstrates ability to triage complex study concerns appropriately

Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits.

Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently.

Data Coordinator Responsibilities:

Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles

Demonstrates the ability to create CRFs, study documents, and tools

Demonstrates ability to resolve complicated queries

Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study.

Regulatory Responsibilities:

Provides logistic and regulatory guidance on FDA-regulated, Investigator-initiated research, and sponsor-initiated research studies.

Provides other administrative support for study activity (including, but not limited to subject reimbursement & payments

Administrative & Training:

Participates in training specific specifically for maintaining certification as a Clinical Research Professional

Supervision Received: This position reports directly to Faculty Principal Investigator.Supervision Exercised: Could provide Functional supervision of staff within the CRC Career Ladder, temps and possible students.Required Qualifications

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 fromSoCRA (https://www.socra.org/certification/certification-program/program-overview/) orACRP (https://acrpnet.org/certification/crc-certification/) )

Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA'sDefinition of a Clinical Research Professional (https://www.socra.org/certification/certification-program/definition-of-a-clinical-research-professional/for) qualifying experience prior to applying.

Desired Qualifications

6+ years of direct related experience

Experience in clinical trials

Experience in Weight Management and Nutrition

Highly desired to hold current SOCRA certification

Work ScheduleThis is a full-time position; remote work is an option.Modes of WorkPositions 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 thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) .Additional InformationMichigan 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 ID257049Working TitleClinical Research Coord InterJob TitleClinical Research Coord InterWork LocationAnn Arbor CampusAnn Arbor, MIModes of WorkHybridFull/Part TimeFull-TimeRegular/TemporaryRegularFLSA StatusExemptOrganizational GroupMedical SchoolDepartmentMM Metabolism, Endo & DiabetesPosting Begin/End Date11/18/2024 - 12/02/2024Career InterestResearchApply Now