"Clinical Research Coordinator – Clinical Interventional/Therapeutic"

About the Job

Job Class: 8351RC, 8352RC Research Professional 1 or 2
Research Coordinator – Clinical Interventional/Therapeutic, DOQ
Working Title: Clinical Research Coordinator
Supervisor: Katie Vera

DESCRIPTION

The Clinical Research Coordinator works under the direction of the Program Manager(s) or Project Lead(s) and is responsible for day-to-day study activities including: participant screening and consent; study visits; data abstraction and entry; implementation of the study protocol; lab kit preparation and collection. The position is responsible for the acquisition, management, tracking and distribution of human tissue samples to collaborating University of Minnesota laboratories. The Clinical Research Coordinator will work across multiple study protocols, supporting various divisions in the Departments served (Department of Surgery and Department of Radiology). This position primarily supports projects within the Department Surgery. Projects include observational, data-driven outcomes research, as well as interventional research projects.

This hybrid position will primarily work independently with day-to-day activities; and report to a Program Manager within the team. The successful candidate should expect to be in the office routinely, 3+ days per week. The ability to work remotely exists and is dependent on work duties (i.e. data only days can be remote). Coordination and biospecimen procurement will take place at multiple clinic and hospital sites, both on and near the UMN campus, and throughout the metro area.

This position is not eligible for visa sponsorship.

Job Duties:

1. Patient Screening, Recruitment, and Consent- 20%
   • Develop methods to identify potential participants such as via database searches and collaboration with internal and external partners.
     RP2 candidates will be expected to independently develop methods to identify and recruit that are compliant with local approvals/guidelines
   • Determine subject eligibility, and maintain compliance with protocol eligibility requirements.
   • Recruit potential subjects
   • Obtain or confirm subject's consent to participate in research.
   • Assess the subject's understanding of the research process, procedures and plan; implement and conduct subject and family education in response to identified needs.
2. Coordinate Participant Activities in Protocol- 30%
   • Assists PI, Program Manager and Research team with all activities relative to initiation of assigned clinical trials.
     RP1 candidates will require introduction to study activities and materials
     RP2 candidates will be familiar with local trial activation and will perform tasks with less direction
   • Assists Regulatory Specialist and Program Manager with drafting study-specific subject consent form documents and recruitment materials according to sponsor and University requirements.
     RP2 candidates will provide feedback based on experience consenting and familiarity with clinical area
   • Coordinate the implementation of the IRB approved protocol.
   • Develop and maintain accurate source documentation.
   • Develop methods to identify potential participants such as via database searches and collaboration with internal and external partners. Maintain accurate and complete study records and supplies.
     RP2 candidates will be expected to independently develop methods
   • Collect and ship specimens for research, laboratory, or clinical testing as required, often in repetitive and concise fashion to maintain integrity across all subject visits.
   • Ensures protocol compliance in biospecimen use and management
   • Build and label kits for biospecimen collection
   • Deliver kits to a draw locations (OR, clinic, locations at the UMMC site, Southdale, and St. John’s)
   • Serve as research support staff for collections taking place in the OR
   • Monitor subject responses to protocol defined treatments/interventions, and schedule required visits and tests.
   • Evaluate laboratory and other findings to determine the presence of expected and unexpected subject reactions or outcomes
   • Assess, troubleshoot, and report problems with data collection or other research processes.
   • Under the supervision of the PI, report study/medical/test results for subjects and/or families and report significant findings to the appropriate study staff.
   • Correctly interpret and comply with applicable Federal Regulations, Good Clinical Practice, and local research regulatory requirements
3. Collect & Abstract Data- 25%
   • Abstract data from medical records and directly enter it into appropriate Research Database.
   • Perform study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records, and personal communications with other healthcare workers.
   • Complete and maintain essential source documentation, regulatory documents, and case-report forms (CRFs)
   • Receive and respond to data queries and monitoring action items as assigned
4. Communication and Training- 15%
   • Coordinate communication between all individuals involved in the research studies (PI, co-PI, sponsor, monitor, clinical staff, other members of the research team, and student employees)
   • Write routine correspondence for research projects including letters, memos, and instructional study forms
   • Interact with study monitors, department, University, and clinical staff to successfully carry out study requirements.
   • Provide ongoing and timely communication on the progress of the study to relevant parties
   • Assist in the training of local staff on the protocol. This includes, but is not limited to: assisting in creation of training materials, delivering education to research and clinical staff, and continually re-educating during the active phase of the research project.
     RP1 will be responsible for day-to-day communication, but will hold less responsibility for onboarding and training others to the protocols
     RP2 are expected to work more independently and articulate/train clinical staff on the protocol
5. Other Duties as Assigned – 10%
   • Assist in REDCap eCRF, consent, or database build-outs and edits
   • Supports other special projects and program initiatives as directed.
   • Attends professional development and training sessions to ensure compliance with newest policies and procedures.
   • RP2s will serve as subject matter expert resource for others on the team with less experience

Qualifications

All required qualifications must be included in the application materials

Required Qualifications for RP1RC:

• BA/BS degree, or a combination of education and relevant work experience to equal at least four years.

Required Qualifications for RP2RC:

• BA/BS degree plus at least two years of relevant experience, or a combination of education and relevant work experience to equal at least six years.

Required Qualifications for RP1RC and RP2RC:

• Computer proficiency, and ability to navigate multiple software applications
• Ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies.
• Possess excellent communication skills; verbal and written.
• Ability to work flexible work hours, including some early mornings, evenings, and weekends and on call as needed for studies. Typical hours will be Monday through Friday, but hours may vary based on study needs, which are based on case times.
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work independently, as part of a team, with changing priorities
• Demonstrated ability to independently meet deadlines and prioritize assignments
• Ability to interact with patient, staff, and research collaborators on a professional level
• Work is performed in an office environment and requires the ability to operate standard office equipment and keyboards. Must have the ability to lift and small carry parcels, packages and other items, to travel short distances, and transport items to study sites.
• Must be able to remain in a stationary position 50% of the time.
• The person in this position needs to move about the campus, between the hospital and clinic, and between our main campus and satellite sites by personal vehicle.

Preferred Qualifications:

• Familiarity with standard medical terminology, research terminology, laboratory environments, basic experimental techniques
• Experience working in a clinical setting
• Experience with human subjects research.
• Certification: National certification in area of specialty or related area preferred. Clinical Research Certification (CCRC or CCRP)
• Experience with EPIC or comparable EMR system.
• Experience with OnCore clinical management system, utilizing Florence and REDCap EDC.

Pay and Benefits

Pay Range: Salary will range between $48,000.00 and $56,000.00 for a RP1RC. Salary will range between $56,000.00 and $63,000.00 for an RP2RC; depending on education/qualifications/experience
Time Appointment: 100% Appointment
Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• 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

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.