Clinical Research Technician (Underfill to Clinical Research Assistant)

Job Summary

Provide all aspects of clinical research coordination. This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity.

Responsibilities

• Knowledge Of 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
• Work directly with multiple radiology research faculty to manage all aspects of assigned clinical trials including but not limited to: IRB submissions, enrolling, and consenting research subjects.
• Completing all aspects of assigned trials, CRF submission, query resolution, IRB reporting including AE and/or ORIO.
• Develop processes and tools to capture data in accordance with ALCOA -C principles.
• Study binder creation and maintenance.
• Sponsor communications, sponsor related activities such as SIV scheduling, monitoring scheduling, and set up.
• Working with internal auditors such as MICHR, Office of Research Compliance, and departmental audits.
• Self-audit assigned trials and assist with auditing other radiology studies.
• Cross coverage on additional trials.

Required Qualifications

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary. Minimum 1 year 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.

Desired Qualifications

• Bachelor's degree is desired. Proficient in research protocol submissions. Some experience with databases such as RedCap and Excel is preferred.
• Excellent verbal and written communications. Candidate must have the ability to communicate concise and accurate information, both verbally and written. An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable. Proven excellent customer service. Ability to foresee the needs of faculty and staff they support and respond accordingly. Critical thinking skills. Ability to quickly understand detailed protocols and develop CRFs, and databases accordingly.