Clinical Trial Assistant
About The Job
The Department of Dermatology Clinical Research Division is seeking a detail-oriented and motivated Clinical Trial Assistant (CTA) to join our research team. In this role, you will support our clinical research operations, ensuring that study protocol documents, scheduling, and data are complete and accurate. The position will support both Investigator-Initiated Trials and Industry-sponsored protocols (Phases I–IV). The CRA will work closely with Clinical Research Coordinators (CRCs) and Principal Investigators (PIs) to facilitate the daily requirements of a diverse portfolio of clinical trials. This position is based out of Minneapolis, MN and is eligible for hybrid work from home and/or on campus work dependent upon individual performance and organizational need, though some regular on-site work will be expected.
Key Responsibilities
Documentation & Data Management (40%)
- Source Documentation: Assist in the creation and maintenance of accurate source documents that capture all participant data during study visits.
- Case Report Forms (eCRFs): Accurately transcribe data from source documents into Electronic Data Capture (EDC) systems, ensuring all entries are timely and compliant with Good Clinical Practice (GCP).
- Clinical Trial Management (Oncore): Enter subject study visits accurately and in a timely manner.
- Data Entry & Query Resolution: Perform routine data entry and work quickly to resolve any data queries or discrepancies identified by study monitors.
Regulatory Compliance (10%)
- Regulatory Binder Management: Maintain the Electronic Essential Documents Binder (eFlorence), ensuring all CVs, licenses are current and updated as necessary.
- Audit Readiness: Assist in preparing for site monitoring visits and potential audits by ensuring all files are organized and "inspection-ready" at all times.
Clinical & Lab Support (50%)
- Subject Recruitment: Assist the team in recruitment and screening to identify candidates for upcoming dermatology pipelines.
- Study Visit Facilitation: Support the clinical team in preparing for participant visits, including scheduling and confirming appointments, and ensuring all necessary supplies for the protocol are available.
- Laboratory Supply Inventory: Maintain adequate available lab kits and shipping supplies for each study. Document and dispose of expired kits.
Qualifications
Bachelor’s degree in Life Sciences, Healthcare, or combination of education and relevant work experience to equal at least four years.
Basic understanding of medical terminology.
Experience providing administrative support and interacting professionally with a wide range of people (i.e., executive leaders, faculty, clinical team members, patients, and visitors).
Skills: Proficiency with Microsoft Office and familiarity with data systems. Strong understanding of HIPAA and GCP guidelines. Exceptional organizational skills and "eagle-eye" attention to detail.
About The Department
The Department of Dermatology is committed to providing excellent patient care, conducting investigational research, and training the next generation of dermatologists. We have world-renowned clinical programs, nationally recognized educational programs, and pioneering clinical trials. We are dedicated to improving dermatological care not only for today, but also for the future.
Pay And Benefits
Pay Range: $23.84-$26.80 per hour; and we anticipate most offers will be around the midpoint of this range, depending on education and experience.
Time Appointment: 75% + appointment
Position Type: Civil-Service
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How To Apply
Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume. Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.
To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.