Center for Veterans Research and Education · 21 hours ago
Clinical Research Coordinator I
The Center for Veterans Research and Education (CVRE) is seeking a Clinical Research Coordinator I to support innovative research and education initiatives that improve the health and well-being of Veterans. This role is responsible for the day-to-day operations of multiple clinical research studies, including patient enrollment and compliance with regulatory requirements.
Non-profit Organization Management
Responsibilities
Maintain close communication with local and network study leadership and staff
Manage the study start-up process, including finalization of Informed Consent Forms and preparation of study start-up materials
Collaborate with the central Institutional Review Board overseeing VA sites, and the local Research and Development Committee (RDC), to ensure that regulatory requirements at the local site are identified, communicated, and observed
Oversee enrollment and study activities with the Site Investigator
Recruit participants, collect data in accordance with established study procedures, follow up with participants in a timely manner
Dispense and track investigational study drug per protocol and in keeping with safe medication handling practices
Conduct phlebotomy and urine sample collection per study protocol
Coordinate home visits between contract Home Health Service and study participants
Monitor subjects' progress, including documentation and reporting of adverse events
Ensure staff and subject compliance with protocol guidelines and requirements of regulatory agencies
Implement protocols to ensure data is collected in a scientifically valid manner
Serve as primary liaison with Site Investigator, staff, internal/external resources and sponsor regarding patient care issues and progress of the study
Maintain local budgets for the study; regularly report progress on all aspects of the project to the Site Investigator
Prepare documentation to support billing for this study’s sub-award, in cooperation with CVRE staff
Track expected and annual payments from the sponsor, in cooperation with CVRE staff
Perform administrative functions including meetings, setting up and participating in conference calls, maintaining written correspondence, and transcribing memoranda
Ensure that study activities are completed in an ethical, culturally responsive, scientifically rigorous, and timely manner in accordance with principles of Good Clinical Practice and Federal Policies for the Protection of Human Subjects
Responsible for alerting the Site Investigator of data collection/protocol breeches, inconsistencies, or other problems that may arise within the study, as well as suggesting methods of correction
Maintain data and study files in accordance with study protocols
Other duties as assigned
Qualification
Required
Bachelor's Degree required
1-3 years of Research Assistant experience, or equivalent education/experience
0-2 years of Coordinator experience required for CRC I
Demonstrated ability to work effectively both independently and as part of a team
Ability to evaluate the quality of data collected and progress toward overall program objectives
Experience in coordinating multiple tasks and project elements with differing timelines and completion deadlines
Excellent oral and written communication skills
Exceptional attention to detail and organizational skills
Proficiency in Microsoft Office products including Outlook, Word, PowerPoint and Excel
Knowledge of Good Clinical Practices, human subjects' protections, and federal regulations relating to clinical research
Subject to a criminal and educational background check
Designated and/or random drug testing may be required
Regular and predictable attendance is required
Typical hours fall within standard business hours, work may be required during hours beyond standard business hours, including weekends
Must be a US citizen
The employee must be able to navigate the medical center, use a keyboard, and lift up to 25 lbs
Preferred
Master's preferred
Preferred working knowledge of the study
Company
Center for Veterans Research and Education
Welcome to the Center for Veterans Research and Education (CVRE) CVRE was established in 1988 to conduct, promote and support the medical research and education activities of the Minneapolis VA Healthcare System and to advance the well being of veterans and the general public by these endeavors.
Funding
Current Stage
Early StageCompany data provided by crunchbase