Job description

Summary: The Center for Veterans Research and Education (CVRE), whose mission is helping to support innovative research and education initiatives that improve the health and well-being of Veterans, is seeking a Research Study Coordinator. Position Description: The CVRE is seeking a full-time Research Study Coordinator for the AMPLITUDE study. AMPLITUDE is funded by Vertex Pharmaceuticals and is a double-blind, placebo-controlled study to evaluate the efficacy and safety of compound VX-147 in people with APOL1-mediated kidney disease. The Research Study Coordinator would be responsible for overseeing study activities as part of a network of VA and non-VA sites. Responsibilities: Major duties and responsibilities may include, but are not limited to the following: • 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. 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. • 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. • Other duties as assigned Applicant must include a cover letter Minimum Qualifications: Education: Bachelors (BA/BS) – Nursing preferred Experience: 3-5 years or equivalent based on degree Licensure/Registration/Certification: Current RN Licensure is preferred Knowledge, Skills and Abilities: • Prior research experience should include data collection and data storage, and Institutional Review Board application processes. • Experience working on previous randomized control trials is preferred. • Experience in coordinating multiple tasks and project elements with differing timelines and completion deadlines. • Experience with electronic medical records preferred. • Strong organizational and interpersonal skills • Demonstrated ability to work effectively both independently and as part of a team. • Excellent oral and written communication skills. • Exceptional attention to detail. • Proficiency in Microsoft Office products including Outlook, Word, PowerPoint and Excel. Conditions of Employment: • 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 Physical Requirements: The employee must be able to navigate the medical center, use a keyboard, and life up to 25 lbs. Reasonable accommodation may be considered in determining an applicant’s ability to perform the duties/functions of the position.

Job Type: Full-time

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Self-determined schedule

Ability to commute/relocate:

• Minneapolis, MN: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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