Clinical Trial Assistant

All required qualifications must be documented on application materials.

Required 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.

Preferred Qualifications:

• 2 years of clinical experience as a medical office assistant, Certified Medical Assistant, or Medical Appointment Scheduler
• Experience supporting complex electronic calendars.
• Experience prioritizing competing projects.
• Experience using MS Office Suite/Google/Epic/OnCore applications.
• Demonstrated commitment to strong customer service, detail oriented, and excellent communication and interpersonal skills.
• Excellent written and oral communication skills.
• Experience supporting more than one professional at a time and prioritizing work.
• Team player with excellent interpersonal skills; enjoys helping people and ability to adjust when project priorities change.
• Expert\-level customer service skills, including both face\-to\-face and on the phone.
• Ability to work with a diverse population.
• Multitasking and working with details, managing workflow while dealing with expected interruptions and meeting deadlines.
• Excellent troubleshooting and problem\-solving skills.
• Ability to make decisions in a timely manner.
• Experience with clinical research recruitment.

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. Because the University of Minnesota is a land\-grant institution that serves the state, residing in Minnesota is typically required.

Key Responsibilities:

1\. 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.

2\. 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.

3\. 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.

Work Environment:

• This position is primarily on\-site to facilitate lab visits and physical document management.
• Must be comfortable handling biological samples and working in a fast\-paced clinical setting.

The Department of Dermatology is committed to providing excellent patient care, conducting investigational research and training the next generation of dermatologist. We have world\-renowned clinical programs, nationally recognized educational program, and pioneering clinical trials. We are dedicated to improving dermatological care not only for today, but also for the future.

For more information, please visit our website at https://med.umn.edu/dermatology.

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\.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world\-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America’s Best Employers (2015, 2018, 2019, 2023\), Best Employer for Diversity (2019, 2020\), Best Employer for New Grads (2018, 2019\), and Best Employer by State (2019, 2022\).