Clinical Research Technician/Assistant

About This Role

This role involves coordinating simple to moderately complex clinical research studies, supporting a portfolio of projects, and mastering the duties of a CRC Assistant. It focuses on patient-oriented, collaborative translational science within a Pediatric Diabetes Research Program.

Responsibilities

• Identify, screen, and enroll potential subjects; consent minimal risk subjects
• Perform data management, such as entering information into Case Report Forms (CRFs)
• Assist with collection of external medical records for study reporting purposes
• Work collaboratively with the CTSU team, maintaining good rapport and communication with research teams and faculty, as well as patients and families
• Coordination of multicenter study and patient engagement efforts
• Collect and manage patient and laboratory data for clinical research subjects
• Maintain oversight to ensure integrity of patient bio specimens (collection, shipping/packing, storing, labeling, tracking, etc.)
• Assist with developing and writing Abstracts/Manuscripts and/or Clinical Trials Protocols
• Assist in the preparation of IRB applications, amendments, scheduled continuing reviews, progress reports, safety reports, and adverse event reports
• Communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject-related problems, recruitment strategies, and specific policies and procedures

Requirements

• Excellent interpersonal, oral, and written communication skills
• Proficient computer skills including Microsoft software applications
• Ability to organize/prioritize tasks effectively and efficiently
• Demonstrated ability to manage work across diverse stakeholders
• Ability to set goals, exercise sound professional judgment, and problem-solve within delegated authority
• Ability to work independently to meet milestones and deadlines
• Solid attendance record and work ethics

Qualifications

• Associate degree in Health Science, advanced degree in a health-related area, or High school diploma/GED.
• Minimum 1 year of directly related experience in clinical research and clinical trials, OR 3 years of human subject experience (clinical, lab or health regulations). Assistant Level requires High school diploma or GED.

Nice to Have

• Bachelor's degree in Health Science
• Understanding of medical terminology
• Experience in a large complex health care setting
• Ability to effectively communicate with staff and faculty of all levels
• Knowledge of university policies and procedures
• Experience and understanding of clinical research or clinical trials
• Experience with the University of Michigan eResearch system
• ACRP or SoCRA certification
• Experience participating in writing manuscripts and progress reports
• Demonstrated good judgment and strong problem-solving skills related to clinical research experience
• Familiarity with REDCap, OnCore, Epic, MiChart, and eResearch applications
• Some knowledge of UMHS policies and practice
• Proven experience in administering IRB/regulatory requirements and protocols

Skills

* Required skills

Benefits