Clinical Research Coord Tech (underfill Asst.)

am.
• 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:
• 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

Supervision Received: This position reports directly to a faculty PI

Supervision Exercised: None

Clinical Research Assistant:
• High school diploma or GED is necessary

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 Assistant:
• Associate 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.

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.

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.