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…