Ann Arbor, MI, USA
1 day ago
Clinical Research Coordinator Associate/Technician/ Assistant- Term limited
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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

This clinical research coordinator (CRC) position with the Department of Anesthesiology, Chronic Pain and Fatigue Research Center may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. This position will require travel from the clinic to the North Campus MRI for study visits. Coordinator experience and mastery of all job duties from the CRC-Associate position on the This clinical research coordinator (CRC) position with the Department of Anesthesiology, Chronic Pain and Fatigue Research Center may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. This position will require travel from the clinic to the North Campus MRI for study visits. 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 be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. The candidate will be expected to be detailed oriented, timely, courteous, and dependable. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

Responsibilities*

Experience as part of a team with 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 Teamwork

Clinical Research Coordinator - Associate

Participant Screening and RecruitmentExplaining study thoroughly, reviewing informed consent, answering any questions, following GCP/IRB and obtaining consent.Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.Demonstrates the ability to document data in accordance with ALCOA-C principles.Describes protocol structure and explains how to interpret study requirements to ensure study compliance.Demonstrates accurate implementation of protocol procedures.Explains and performs study related management activities.Performs study procedures with minimal supervision.Triages subject issues appropriately.Schedules and runs study visits with complex data collection.Perform Quantitative Sensory Testing (QST) inside and outside of MRI, and willingness to be trainedPreparation datasheets, questionnaires, study related documentsTracking and communication with study subjectsComplete subject documentation and follow up Assist with data entry and captureEnsures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.Submit Human Subjects Incentive Program (HSIP) requestsAssist with eResearch submissionsTravel to the North Campus MRI for study visits or Research Pharmacy

Clinical Research Coordinator - Technician

This position provides study coordination for simple and moderately complex clinical research studies. As a member of the research team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Assistant position is required.

Performs moderately complex study procedures with accuracy.Tracking and communication with study subjectsTriages subject concerns appropriately.Assesses studies for execution and troubleshoots potential implementation issues.Completes simple to moderately complex data collection during study visits.Assists with local quality control efforts.Submit  Human Subjects Incentive Program (HSIP) requestsAssist with data entry and captureTravel to the North Campus MRI for study visits or Research Pharmacy

Clinical Research Coordinator - Assistant

This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. Demonstrates the ability to screen participants for study eligibility.

Performs study procedures with accuracy.Tracking and communication with study subjectsUnderstands protocol structure and how to interpret study requirements to ensure study compliance.Understands proper documentation techniques, as outlined in the ICH-GCP guidelines.May assist research coordinator in conduct of SIV; attends SIV.May assist in and attend monitor visits and/or audits.Submit  Human Subjects Incentive Program (HSIP) requestsAssist with data entry and captureTravel to the North Campus MRI for study visits or Research Pharmacy

Supervison recevied: This position reports directly to a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator.

Supervison excerised: None 

Required Qualifications*

CRC Associate:

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 2 years of directly related experience in clinical research and clinical trials is necessary.Attention to detail and accuracyExcellent attendance and strong work ethic in past settingsExcellent interpersonal skillsDemonstrated ability to prioritize and exercise good judgement

CRC Technician:

Associate degree in health science or an equivalent combination of related education and experience is necessary. Minimum 1 year directly related experience in clinical research and clinical trials is necessary or an advanced degree in a health-related area such as Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD or minimum 3 years of human subject experience (clinical, lab, or health regulations) such as related patient care, related community health and wellness, related clinical information, and research. Attention to detail and accuracyExcellent attendance and strong work ethic in past settingsExcellent interpersonal skillsDemonstrated ability to prioritize and exercise good judgement

CRC Assistant:

High School DiplomaAttention to detail and accuracyExcellent attendance and strong work ethic in past settingsExcellent interpersonal skills
Desired Qualifications*

CRC Associate:

4+ years of direct related experiencePhlebotomy experienceLab processing experienceExperience with eResearchPediatric research experience

CRC Technician:

Bachelors Degree in Health Science or an equivalent combination of related education and experience is desirable.Phlebotomy experienceLab processing experiencePediatric research experience

CRC Assistant:

Associate degree or equivalent combination of education and experience; Health Science is preferredPhlebotomy experienceLab processing experienceWork Schedule

Monday-Friday in person, on-site, with the requirement of schedule flexibility for occasional early morning, late afternoon/early evening, and on rare occasion weekends as needed. This is not a remote position.  Monday-Friday in person, on-site, with the requirement of schedule flexibility for occasional early morning, late afternoon/early evening, and on rare occasion weekends as needed. This is not a remote position. 

Work Locations

Domino Farms, Lobby M, Ste 3100 

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 here.

Underfill Statement

This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates qualifications.

Additional Information

This position is term-limited for 2 years with the possibility of renewal based on need and available funding.  At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits.  This term-limited appointment does not create a contract or guarantee

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 Statement

The University of Michigan is an equal employment opportunity employer.

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