This is the entry level position on the Michigan Medicine CRC Career Ladder. This position provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.
Characteristic Duties and 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
Performs simple study procedures with accuracy.
Performs clerical duties, including, but not limited to, mailing and filing correspondence, calling patients and obtaining medical records.
Performs moderately complex study procedures with accuracy.
Triages simple subject concerns and issues appropriately.
Assesses studies for execution and troubleshoots potential implementation issues.
Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
Completes simple to moderately complex data collection during study visits.
May work with CTSUs to reconcile financial accounts for study participants.
Assists with local quality control efforts.
May create a recruitment plan that addresses the needs of the study population and develop materials for IRB submission that will aid in recruitment
May assist research coordinator in conduct of Site Initiation Visit (SIV); attends SIV
May assist in and attends monitor visits and or audits.
Ability to assist with regulatory aspect of clinical trial management.
Prepare study procedure kits, shippers, CRFs, and requisition forms.
Ability to work independently or as a member of a team
Exceptional organizational and computer skills in Microsoft software applications.
Ability to work with minimal supervision while maintaining productivity standards
Demonstrated problem solving and conflict resolution skills.
Ability to multi-task, work well under time constraints and meet deadlines.
Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail and exercise of good judgement.
Perform other related duties as assigned.
Understands importance of participant confidentiality and complies with HIPAA and U of M regulations
Demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures related to the ethical treatment of participants
May work with Office of Research Compliance to create and post studies in ClinicalTrials.gov.
May obtain the CTN number for eResearch applications.
Completes simple to moderately complex CRFs.
Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC)
May assist in CRF development for Investigator Initiated trials.
Regulatory Coordinator Responsibilities (ex. - Submission and management of IRB applications; Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs) and report appropriately.)
