The Division of Rheumatology Scleroderma team is looking for a highly motivated, self-starting Clinical Research Technician to manage clinical trials and observational studies for the program. In this role, you will be supporting a multidisciplinary team of researchers and healthcare professionals dedicated to advancing research and improving care for patients with scleroderma and its related complications.
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. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.
Clinical Research Technician/Assistant Underfill
- Performs study procedures with minimal supervision; Schedules, assists with preparation for, and attends study initiation meetings, monitors, and audits; Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.)
- Demonstrate understanding of protocol elements/requirements and demonstrate the ability to execute study procedures.
- Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance.
- Describe protocol structure and explain how to interpret study requirements to ensure study compliance.
- Demonstrate accurate implementation of protocol procedures.
- Explain and performs study non-GCP related study management activities.
- Perform study procedures with minimal supervision.
- Triage simple subject concerns and issues appropriately.
- Schedule, preparation and attendance in study initiation meetings, monitor visits, and audits.
- Ensure integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
- Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.
Data Coordinator Responsibilities
- Demonstrate the ability to document data in accordance with ALCOA-C principles.
- Explain how to utilize information from the EMR and study databases.
- Completes complex data collection during study visits.
- Demonstrates ability to resolve data queries.
Regulatory Coordinator Responsibilities
- Recognize situations requiring prompt escalation and demonstrate actions to minimize risks
- Explain and perform study operational activities in compliance with Good Clinical Practice (GCP)
- Explain proper documentation techniques as outlined in the ICH-GCP guidelines.
- Explain the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other
- Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them.
- Work with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT.
- Demonstrates understanding of University and Federal guidelines to assist with Investigator Initiated studies.
- Collaborate with MIAP for INDs and IDEs.
- Demonstrate an understanding of the elements of subject safety, related documentation, and reporting.
- Recognize situations requiring prompt escalation and demonstrates actions to minimize risks.
- Demonstrate proficiency in all eResearch applications and submissions, such as continuing renewals and amendments.
- Demonstrate ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
- Maintenance of updated regulatory documentation.
- Explain the investigational products development process and identify key regulations to control these processes
Administrative Responsibilities
- Assist with creating posters, abstracts, and articles
- Participate in regular study meetings.
- Properly completes payment forms and pays participants accordingly
- Other Responsibilities: Additional duties as assigned
Training
Participates in trainings specifically for certification as a Clinical Research Professional
- All training requirements of previous level.
- PEERRS, HIPAA, CITI GCP
- eRPM Regulatory training
- Attends and participates in all training assigned to this level
Characteristic Duties and Responsibilities:
Set-up unit wide systems or policies and manage a team of clinical research professionals (or portfolios) in 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 CRC-Lead
Supervision Exercised: None
Technician Level:
- 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 SoCRA's 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.
Assistant Level:
- High school diploma or GED is necessary.
Technician Level:
- 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.
Assistant Level:
- 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.
This position will be onsite 5 days per week.
This position may be underfilled at the CRC-Assistant title based on selected candidates' qualifications.
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 d
