Research Professional 2 - Lillehei Clinical Research Unit/Cardiovascular

About the Job

• Duties are determined by protocol‑specific requirements and will include research activity from study startup through closeout and following participants from beginning to completion of the study.
• Follow Good Clinical Practice (GCP) guidelines in the conduct, performance and documentation of clinical research activities.
• Complete and maintain necessary training for safety, regulatory, facility access, and data system access.
• Facilitate study startup activities following guides and checklists to implement protocols, assess study related needs, create source documentation, visit checklists, and logs or other documents as required.
• Recruit interested individuals to participate in research projects and engage with the study team in verifying subject eligibility, facilitating subject enrollments, and ensuring compliance in the completion of research activities.
• Facilitate the completion of participant visits by scheduling appointments with participants and clinical staff following the protocol, providing necessary instructions, materials and reminders to participants, booking rooms, registering participants, and other tasks as needed.
• Obtain informed consent and assent, including assessments of capacity to consent to research. Obtain re‑consent as needed.
• Conscientiously conduct research study activities to protect and promote participant safety, communicating clearly and promptly about any potential concerns.
• Communicate information about assigned studies to other University faculty/staff, including details of study, inclusion/exclusion criteria, other enrollment requirements, visit needs, etc., leading training of study staff, clinical, and lab partners on study protocols activities as it relates to their roles on the study.
• Collaborate with the principal investigator/study team and with clinical providers and other departments to ensure smooth implementation and operation of the research protocol and study specific procedures are completed.
• Effectively work independently in multiple locations with hospital and clinic staff to complete research related tasks.
• Collect data and conduct assessments as part of study specific visits, in‑person or remotely, following protocol specific guidelines, including data abstraction from medical records.
• Oversee specimen management for multiple projects, including monitoring the collection, processing, and storage or compliant shipment of research specimens to research laboratories, and return of results.
• Correctly and accurately complete source documentation for participant study‑related visits along with other required documentation as needed; engage with providers and investigators to ensure adequate source documentation is available.
• Support timely and quality data submission and maintenance of participant research records.
• Complete and ensure appropriate documentation for any adverse‑event (AE), serious adverse event (SAE) and protocol deviation, complying with reporting regulations and timelines, and notifying appropriate individuals/entities per research requirements.
• Use University systems such as Florence, OnCore, Box, Smartsheet, and REDCap to maintain information for all necessary research documentation.
• Monitor study supplies and equipment, proactively ordering new as well as disposing of expired/unused items when needed, maintaining organization of items.
• Prepare for, schedule, and participate in pre‑site selection visits, site initiation visits, monitoring visits, and program audits by coordinating the visits and schedules, leading facility tours, and ensuring requested information is provided.
• In collaboration with the research team, interpret study protocols and inform the development of consent forms and other materials needed for each clinical research study.
• Maintain regulatory documents, such as enrollment logs; participant visit logs; protocol deviation logs; etc.

Qualifications

All required qualifications must be included in the application materials.

Required Qualifications

• BA/BS in a health related field plus 2 years of work experience in clinical research or a combination of related education and work experience in clinical research totaling 6 years.
• Ability to work independently, make decisions, problem solve, maintain deadlines, and prioritize the simultaneous management of multiple clinical studies.
• Ability to follow strict protocols with the utmost ethical standards.
• Knowledge of clinical research compliance standards, e.g. informed consent process, adverse event reporting, the Code of Federal Regulations (CFR) and Good Clinical Practice (GCP) Standards.
• Computer proficiency and ability to navigate multiple software applications; experience with computerized data management.
• Demonstrated accurate data management skills, such as data collection, data entry and quality control.
• Excellent written, verbal and interpersonal skills.
• On‑site work 5 days per week.
• Additional requirements per Fairview Research Administration may include proof of non‑active tuberculosis and immunization for (or resistance to) measles, mumps, rubella, Hepatitis B, and pertussis and influenza. Additional background checks will be completed by Fairview Health Services as a condition of employment in this position.

Preferred Qualifications

• Experience with business & industry trials.
• Familiarity with the research policies and procedures at the University of Minnesota, University of Minnesota Medical Center, Fairview Hospitals and Clinics.
• Experience with EPIC or other electronic medical records systems.
• Proven detail‑oriented with exceptional organizational, planning and problem‑solving skills and ability to meet deadlines.
• Certification as a Clinical Research Coordinator, or qualified to sit for the certification exam.
• Phlebotomy experience.

Pay and Benefits

Pay Range: $55,000-$70,000; depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: Civil‑Service & Non‑Faculty Labor Represented Staff

We encourage your educational and professional development through opportunities such as the Regents Tuition Benefit Program and other professional training and degree‑seeking programs.

Competitive wages, paid holidays, and generous time off.

Low‑cost medical, dental, and pharmacy plans.

Healthcare and dependent care flexible spending accounts.

University HSA contributions.

Disability and employer‑paid life insurance.

Employee wellbeing program.

Excellent retirement plans with employer contribution.

Public Service Loan Forgiveness (PSLF) opportunity.

Financial counseling services.

Employee Assistance Program with eight sessions of counseling at no cost.

Employee Transit Pass with free or reduced rates in the Twin Cities metro area.

While our salary ranges provide a framework, it is important to note that most of the time the initial pay may not reach the maximum of the range. This approach ensures that compensation reflects the value and unique contributions of each candidate while maintaining equity within our organization.

As part of our commitment to fair and equitable compensation, please be aware that the salary offered to incoming candidates will be based on their individual credentials and experience.

Diversity

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:

Employment Requirements

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.