Clinical Research Coord Inter

University Of Michigan; Brighton (MI); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental & vision coverage

2:1 retirement match

Job summary

University of Michigan is seeking a Clinical Research Coordinator Intermediate for the Oncology CTSU Clinic Research Group, based at the Brighton Center for Specialty Care. You will provide administrative study coordination and clinic support to faculty and research teams within the Rogel Cancer Center.

The role requires a Bachelor's degree in Health Science or related field, plus certification eligibility (ACRP/SoCRA) with completion within six months.

Qualifications

• Bachelor's degree in Health Science or related field.
• Certification in CCRP/CCRP within six months of hire or equivalent eligibility.

Responsibilities

• Performs study procedures with accuracy.
• Triages complex study concerns appropriately.
• Manages increasing protocol complexity and volume efficiently.
• Develops processes to capture data in accordance with ALCOA-C principles.
• Provides regulatory guidance on Investigator Initiated Studies.
• Supports subject reimbursement and payments.
• Participates in training to maintain Clinical Research Professional certification.
• Monitors site compliance and improves subject safety during conduct of studies.
• Understands Investigational products development and regulatory requirements.
• Responsible for research sample processing.

Skills

Clinical Research Coordination

Regulatory Compliance

Data Management

Education

Bachelor's degree in Health Science / related field

Certification eligibility (ACRP/SoCRA) within six months of hire

Tools

eClinical systems knowledge

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 Intermediate in the Oncology Clinical Trial Support Unit (O-CTSU) - Clinic Research Group located in the Brighton Center for Specialty Care providing administrative study coordination and clinic 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 Michigan Answers TM . Help discover them.

This Clinical Research Coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. 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 elevate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

Responsibilities*

Characteristic Duties and Responsibilities:

Independent 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

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 and will be located at the Brighton Center for Specialty Care (BCSC) in Brighton. The coordinator may sometimes have to come to Ann Arbor location for training and to provide help when needed. Examples of duties a successful candidate in this role will perform:

• Performs study procedures with accuracy.
• Demonstrates ability to triage complex study concerns appropriately.
• Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently.
• Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles.
• Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines.
• Provide other administrative support for study activity including management of subject reimbursement and payments.
• Participates in training's specifically for maintaining certification as a Clinical Research Professional.
• 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.
• Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes.
• Responsible for Research sample processing.

Required Qualifications*

• Bachelor's degree in Health Science or an equivalent combination of related education and 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 )

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 30,000employees 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.
• This position is located at Brighton (BCSC). May have to come to Ann Arbor location for training or to provide help/coverage when needed.

Underfill Statement

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

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 maybegin as early as the eighth day after posting.Thisopening 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.