Clinical Research Coord Assoc/Technician/Assistant

Michigan Medicine; Ann Arbor (MI); Hybrid; USD 52,000 - 76,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

2:1 retirement match

Job summary

Michigan Medicine is seeking a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) - Clinic Research Group at Rogel Cancer Center. The role supports administrative study coordination and data entry for faculty and research teams in a leading NCI-designated cancer center.

You will join a team of professionals dedicated to cutting-edge early phase trials to practice-changing phase III, with opportunities for education, training and career advancement in a

Qualifications

• Bachelor's Degree in Health Science or equivalent in combined education and clinical research experience.
• ACRP-CCR CCRC or SoCRA-CCRP certification required or eligible; certification to be completed within six months of hire.
• Minimum 2 years of directly related experience in clinical research and clinical trials.

Responsibilities

• Execute protocol elements and study procedures with understanding of protocol requirements.
• Mitigate potential protocol non-compliance and ensure study safety and ethical considerations.
• Manage data collection, specimen integrity and regulatory documentation across CTRU duties.

Education

Bachelor's Degree in Health Science or equivalent

Associate degree in Health Science or related education/experience

High School Diploma or GED

Tools

EMR

CTMS

EDC

Job description

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.

Job Summary

This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) - Clinic Research Group located in the Rogel Cancer Center providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 175 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers?. Help discover them.

Responsibilities*

Characteristic Duties And Responsibilities

• 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

Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role. The clinical research coordinator hired for this posting will specialize in Clinic. Examples of duties a successful candidate in this role will perform:

Clinical Research Coordinator - Associate

• 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.
• Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
• Demonstrates accurate implementation of protocol procedures.
• Explains and performs non-GCP-related study management activities.
• Performs study procedures with minimal supervision.
• Triages simple subject issues appropriately.
• Ensures 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.
• Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing.

This position reports directly to a CRC-Lead, CRC-Project Manager, or a unit Administrator, Director.

Clinical Research Coordinator - Technician

• Performs moderately complex study procedures with accuracy.
• Triages simple subject concerns appropriately.
• Assesses studies for execution and troubleshoots potential implementation issues.
• Completes simple to moderately complex data collection during study visits.
• May work with CTSUs to reconcile financial accounts for study participants.
• Assists with local quality control efforts.

Clinical Research Coordinator - Assistant

• Demonstrates the ability to screen participants for study eligibility.
• Performs simple study procedures with accuracy.
• Understands protocol structure and how to interpret study requirements to ensure study compliance.
• Understands proper documentation techniques, as outlined in the ICH-GCP guidelines.
• May complete simple study reimbursement with partners such as the Human Subjects Incentive Program (HSIP) and the CTSU finance team.
• Demonstrates the ability to find and utilize information from EMR and databases/CTMS/EDC.
• May mark visits as planned/occurred in OnCore.
• May provide lab results, not interpretation, to participants.
• May assist research coordinator in conduct of SIV; attends SIV.
• May assist in and attend monitor visits and/or audits.

Required Qualifications*

Clinical Research Coordinator - Associate

• Bachelor's Degree in Health Science or equivalent in combined education and clinical research experience
• 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)
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.

Clinical Research Coordinator - Technician

• Associate degree in Health Science or an equivalent combination of related education and experience.
• ONE of the following:
  • Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
  • An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
  • 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.

Clinical Research Coordinator - Assistant

• High School Diploma or GED

Desired Qualifications*

Clinical Research Coordinator - Associate

• 4+ years of direct related experience

Clinical Research Coordinator - Technician

• Bachelor's Degree; Health Science field preferred or related certification
• Understanding of medical terminology
• Experience in a large, complex, healthcare setting
• Ability to effectively communicate with staff and faculty of all levels
• Knowledge of University policies and procedures

Clinical Research Coordinator - Assistant

• Bachelor's Degree, Associate Degree, some college; Health Science field preferred or related certification
• Understanding of medical terminology
• Experience in a large, complex, healthcare setting
• Ability to effectively communicate with staff and faculty of all levels
• Knowledge of University policies and procedures

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

Monday through Friday, core business hours. Occasionally evening or weekend work to meet deadlines or support patient care.

Underfill Statement

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

Additional Information

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 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 Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

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 any time 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.