"Clinical Research Technician"

This position will serve as a Clinical Research Coordinator Technician in the Oncology Clinical Trial Support Unit (O-CTSU) - providing biospecimen processing and management support to faculty and research teams at 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.

Characteristic Duties and Responsibilities: Knowledge of 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

Responsibilities will include, but are not limited to: Technician Level - Clinic Coordination: Understands clinical research protocol structure, associated lab manuals, etc. and how to interpret study requirements to ensure compliance. Assists with set up kits for research draws, perform quality checks and troubleshoot potential implementation issues with partnered coordinators. Performs moderately complex sample management (e.g. processing, storage, and transport) according to study documents for all supported clinical trials and biorepositories. Ships research samples per protocol including coordinating with study sponsor's receiving sites via e-mail or phone as required. Assist unit supervisor and other CRCs with tissue management (e.g. processing, accessioning and shipping). Assist unit supervisor with batch shipments of samples per sponsor requirements. - Data Coordination: Demonstrates the ability to complete data collection in recording sample disposition (freezer location or shipping tracker information). Performs complete and accurate documentation on moderately complex requisition forms, shipping documents, clinical trials management systems and other potential sponsor systems. Can resolve simple to moderately complex queries. Performs quality checks on existing calendars and troubleshoot visit specific templates in the clinical trials management system (e.g., OnCore). Creates unscheduled and visit specific templates in the clinical trials management system (e.g., OnCore). Works with CTSU finance regarding billing considerations for studies. Checks own work and confirms accuracy. - Regulatory Coordination: Demonstrates understanding of essential documents as described in the ICH-GCP guidelines. Assists with maintenance of internal study guidance documents per study amendments. Performs and records routine instrument maintenance procedures; (ex. temp logs, scraping freezers reviewing nitrogen supply, etc.), assisting with internal/external audits. Identifies and communicates protocol deviations and quality issues with unit leadership and assist with appropriate ORIO procedures (i.e. Other Reportable Information or Events). - Administrative: May manage study supply inventory. - Training: Attending and participating in all training classes assigned to this level (Ex: PEERRS, HIPAA, CITI GCP). Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned. Willing to learn and use available technology and systems to accomplish job requirements.

Supervision Received: This position receives direct supervision and reports directly to the unit leader. Supervision Exercised: None

Assistant Level duties are similar but at a lower complexity.

Qualifications: For Technician Level: Associate degree in Health Science or equivalent, minimum 1 year of directly related experience. For Assistant Level: High School diploma or GED, Bachelor's degree desirable, understanding of medical terminology.

Hours/Week: 40 hours, Shift as assigned to support unit operational hours Monday thru Friday from 7a - 6p.