Research Professional 1-Rsch Coord-Cln I/T
About The Position
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.
Requirements
- BA/BS or a combination of relevant education & healthcare or research experience to equal 4 years.
- Excellent attention to detail and organizational skills
- Ability to work independently, as part of a team, and with changing priorities
- Computer proficiency in a PC environment including Microsoft Office products
- Ability to sit for extended periods of time
Nice To Haves
- Experience abstracting clinical data and familiarity with medical terminology
- Oncology research experience in an academic setting
- Clinical Research Coordinator certification
- Experience with Epic, Oncore, or equivalent medical record / Clinical Trial Management Systems
Responsibilities
- Serves as primary contact for the collection and completion of required study documentation
- Develops and maintains study documentation to ensure audit-proof compliance
- Abstracts data from medical record to ensure accurate and complete source documentation
- Manages electronic data capture systems, including but not limited to developing case report forms, responding to queries, and meeting data lock deadlines
- In collaboration with the Principal Investigator, interprets protocols and creates source documents needed for clinical research study
- Identifies and reports protocol deviations within the required timeline in accordance with institutional requirements
- Coordinates visits with sponsors, monitors and other key collaborators, including site initiation visits, interim monitoring visits and closeout visits
- Collaborates with PI and study team to enroll study participants, execute study-required procedures, and maintain accurate source documentation
- Maintains a processing and tracking system for protocol-required biospecimens, data, and procedures
- Works as a member of the study team with positive and timely written and verbal communication, including sharing information up, down, and laterally
- Troubleshoots problems in the development and implementation of protocol procedures
- 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Educational Services
Number of Employees
5,001-10,000 employees
