Clinical Research Coordinator Intermediate

Kappaalphapsi1911; Ann Arbor (MI); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Retirement matching

Job summary

Michigan Medicine is seeking a Clinical Research Coordinator to support the Scleroderma Program within the Division of Rheumatology. You will coordinate multiple studies, implement procedures, and mentor staff to ensure compliant study conduct.

Key duties include data entry, regulatory handling, subject recruitment, and collaboration with the Research Pharmacy. A Bachelor’s in Health Science and RCR/CCRC or SOCRA certification is required, with 3+ years of clinical research experience; 6+ years

Qualifications

• Direct involvement in clinical research and trials.
• Knowledge of Good Clinical Practice (GCP) and IRB processes.
• Ability to guide and mentor study team members.

Responsibilities

• Coordinate multiple clinical studies for the Scleroderma Program.
• Develop and implement study procedures, tools and training.
• Ensure data quality, regulatory compliance, and accurate documentation.
• Manage subject recruitment, consent, and study visits.
• Handle biospecimens and lab samples as needed.
• Collaborate with Research Pharmacy and IP management.

Skills

Clinical Research

GCP/IRB Knowledge

Mentoring/Training

Education

Bachelor's degree in Health Science

Job description

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.Job SummaryThe clinical research coordinator (CRC) position will provide study coordination for multiple clinical research studies of varying complexity for the Scleroderma Program in the Division of Rheumatology. 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 including developing 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.

Responsibilities

• The position is looking to hire a coordinator with expertise in conducting pharmaceutical-funded & investigator -initiated clinical studies and trials.
• Contribution to the development of process and tools in all 8 competency domains is expected:Scientific Concepts and Research DesignEthical Participant Safety ConsiderationsInvestigational Products Development and RegulationClinical Study Operations (GCPs)Study and Site ManagementData Management and InformaticsLeadership and ProfessionalismCommunication and TeamworkParticipant Screening and RecruitmentExplaining study thoroughly, reviewing informed consent, answering any questions, following GCP/IRB guidelines and obtaining consentDemonstrates ability to triage complex study concerns appropriatelySchedules, prepares for, and attends study initiation meetings, Independent Monitoring Committee (IMC) meetings, monitor visits, and auditsDemonstrates ability to manage increasing levels of protocol complexity and/or volume efficientlyCollection of patient bio specimens and disease activity measures; ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.)Various duties as neededStudy Interactions and CollectionAttain in-depth understanding of study protocol and objectives to assist with successful implementation of all study proceduresDemonstrates the ability to create CRFs, study documents, and toolsDemonstrates ability to resolve complicated queriesScheduling and completing subject visits or follow up interactionsPreparation of datasheets, questionnaires, study related documents as neededTracking and communication with study subjectsComplete subject documentation and follow upSpecimen handling, process lab samples, manage laboratory samples and shippingSubmit Human Subjects Incentive Program (HSIP) requestsData Entry and ManagementAssist with data entry and captureResponsible for data entry and management for studyChart abstractions of data to enter in database(s) and source documentationDemonstrates ability to resolve complicated queriesTakes an active role in ensuring data qualityReview collected data and perform data quality assurance of the collected data with the study monitorDemonstrates expertise in data collection, data management, and results reportingVarious duties as neededRegulatoryPrepare Institutional Review Board research applications and reporting; update and maintain IRB recordsFacilitate monitoring visits on regulatory complianceFacilitate Independent Monitoring Committee meetingsAdd new clinical trials and update existing clinical trials at Clinicaltrials.gov.Working with Research Pharmacy, Investigational Product (IP) management and accountability
• Supervision Received: This position reports directly to Faculty Principal Investigator.Supervision Exercised: Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.

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 from SoCRA or ACRP 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 Professionalfor qualifying experience prior to applying.)

Desired Qualifications

• 6+ 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

This position will be mostly in-person with an expectation of 4-5 days per week onsite.

Underfill Statement

This position may be underfilled at the CRC-Intermediate title based on selected candidates qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

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 any U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days.The review and selection process maybegin as early as the eighth day after posting.Thisopening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.

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