"Clinical Research Coord Assoc/Technician/Assistant"

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.

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 150 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.

This clinical Research Coordinator (CRC) position my 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-Technician 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. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

Characteristic Duties and Responsibilities:

Independent knowledge, skills, and abilities within all 8 competency domains is expected:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. 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. 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.

Clinical Research Coordinator - Associate

Required Qualification: 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.
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary.

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.
  • 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

Clinical Research Coordinator - Associate (Desired Qualification)

• 4+ years of direct related experience

Clinical Research Coordinator - Technician (Desired Qualification)

• 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 (Desired Qualification)

• 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

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

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