"Clinical Research Coord Assoc"

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) 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 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-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

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

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 Regulatory. Examples of duties a successful candidate in this role will perform:

Clinical Research Coordinator - Associate

• Explains and performs study operational activities in compliance with Good Clinical Practice (GCP).
• Explains proper documentation techniques as outlined in the ICH-GCP guidelines
• Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them.
• Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT.
• Demonstrates understanding of University and Federal guidelines in order to assist with Investigator Initiated studies.
• Collaborates with MIAP for INDs and IDEs.
• Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
• Demonstrates proficiency in all eResearch applications and submissions, such as continuing renewals and amendments.
• Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• Maintenance of updated regulatory documentation.
• Explain the investigational products development process and identify key regulations to control these processes.

Clinical Research Coordinator - Technician

• May complete new eResearch applications.
• May maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• May gather participant approval via informed consent.
• Prepares and participates in internal and external audits.
• Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
• Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately.

Clinical Research Coordinator - Assistant

• May work with regulatory support to collect essential documents and maintain regulatory binder (CVs), MD licenses, lab certifications, IRB rosters, lab norms, etc.)
• Assists with AEs and SAEs, ORIOS reporting; Uses proper documentation techniques as outlined in the ICH-GCP guidelines.
• Demonstrates understanding of the clinical research objectives associated with the program.
• May assist research coordinator in conduct of SIV; attends SIV.
• May assist in and attends monitor visits and or audits.

Required Qualifications - Clinical Research Coordinator - 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 within six months of date of hire.
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary.

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.