Clinical Research Technician / Assistant

About the role

Mission Statement 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.

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.

Responsibilities

• 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
• 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

Requirements

• 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
• Assistant Level: High school diploma or GED is necessary

Qualifications

• 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

Benefits

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings
• Modes of Work Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department

Schedule

This position will be onsite 5 days per week