"Clinical Research Coord Tech (underfill Asst.)"

Applicants can join a long-standing GI- Hepatology research group currently conducting clinical research in liver disease. There are ongoing observational registry studies as well as clinical trials involving novel therapies. Work is dynamic and multifaceted. The team is interested in adding a new research Tech/ assistant who brings curiosity, organizational skills, and critical thinking to the team.

• Clinical coordinator- After completion of team training, learns to consent and enroll patients into observational studies and clinical trials. Performs study visits including pre-visit preparation, data and biosample collection during visits, shipping of materials and data entry. Arranges follow-up protocol study visits. Interfaces with data coordinating site and monitors.
• Data coordinator-Works to address data queries, site monitoring visits, conference calls, data entry into web based systems
• Regulatory-submission and management of IRB applications, ORIO’s, and adverse events. Assist with completing new e-research applications ; maintaining reg binders. Interfacing with sponsors.
• Administrative-Collection and processing of biosamples and data, data entry, scheduling patients. Assisting with recruitment efforts with internal and external medical providers. Obtaining outside records and tissue samples.

Characteristic Duties and Responsibilities:
Expert level 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

Supervision Received: This position reports directly to a faculty PI

Supervision Exercised: None

Clinical Research Technician:

• 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. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.) or 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. or 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 Technician:

• Bachelors degree in Health Science or an equivalent combination of related education and experience is desirable.
• 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.
• Minimum 1-2 years of prior work experience in health care and ideally a clinical or research position preferred.

Both:

• Use of excel, word, and web-based databases preferred.
• Will need to get PEERS, HIPPA, and on the job training with certification in various areas of clinical research.

M-F normal business hours and onsite

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.