Clinicla Research Coordinator 1 - Military Veterans
at HERC- Upper MidWest
The Clinical Research Coordinator I is responsible for providing technical expertise and overall management of clinical research data collection, study documentation, protocol-required
procedure execution, and collaboration with PI and study team to ensure consistent and accurate implementation of the protocol. The incumbent will be expected to follow Good Clinical Practice (GCP) and all organizational policies and procedures for patient safety and data integrity, including but not limited to the Institutional Review Board (IRB), Food & Drug Administration (FDA), Code of Federal Regulations (CFR), and International Conference on Harmonization (ICH) guidelines.
SPECIFIC RESPONSIBILITIES
Data Management (70%)
â- Serves as primary contact for the collection and completion of required study
documentation
â- Develops and maintains study documentation to ensure audit-proof compliance
â- Abstracts data from medical record to ensure accurate and complete source
documentation
â- Manages electronic data capture systems, including but not limited to developing case
report forms, responding to queries, and meeting data lock deadlines
Study Coordination (30%)
â- In collaboration with the Principal Investigator, interprets protocols and creates source
documents needed for clinical research study
â- Identifies and reports protocol deviations within the required timeline in accordance with
institutional requirements
â- Coordinates visits with sponsors, monitors and other key collaborators, including site
initiation visits, interim monitoring visits and closeout visits
â- Collaborates with PI and study team to enroll study participants, execute study-required
procedures, and maintain accurate source documentation
â- Maintains a processing and tracking system for protocol-required biospecimens, data,
and procedures
â- Works as a member of the study team with positive and timely written and verbal
communication, including sharing information up, down, and laterally
â- Troubleshoots problems in the development and implementation of protocol procedures
â- Coordinates with Investigational Drug Services (IDS), BioNet, clinical staff, and other
departments across campus to deliver drug, collect biospecimens, and execute the
study visits according to protocol
All required qualifications must be documented on application materials.
REQUIRED QUALIFICATIONS
â- BA/BS degree, or a combination of education and research or health care work experience to equal at least four years.
â- Excellent attention to detail and organizational skills
â- Ability to work independently, as part of a team, and with changing priorities
â- Computer proficiency in a PC environment including Microsoft Office products
â- Ability to sit for extended periods of time
PREFERRED QUALIFICATIONS
â- Oncology research experience in an academic setting
â- Experience abstracting clinical data and familiarity with medical terminology
â- Clinical Research Coordinator certification
â- Experience with Epic, Oncore, or equivalent medical record / Clinical Trial Management
Systems
Minneapolis, MN
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