Clinical Research Operations Manager Jobs in Maple Grove, MN

Job Title:           Clinical Research Coordinator

Location:          Minneapolis VA Medical Center

Job Code:          CRC, Full-Time, Benefits-Eligible, Exempt

Supervisor:    Principal Investigator

Project: 

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 Clinical Research Coordinator

Position Description:

The Clinical Research Coordinator is responsible for the day-to-day operations of multiple clinical research studies. This position will actively enroll patients at the Minneapolis VA Medical Center.

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.

• Ensure that study activities are completed in an ethical, culturally responsive, 

   scientifically rigorous, and timely manner in accordance with principles of Good Clinical 

• Other duties as assigned

Applicant must include a cover letter

Minimum Qualifications:

Education:   Bachelor’s Degree required (Master’s preferred)

Experience: 2-3 years of Research Assistant experience

0-2 years of Coordinator experience required for CRC I

2-4 years of Coordinator experience required for CRC II

                                                Preferred working knowledge of the study

Licensure/Registration/Certification: None

Knowledge, Skills, and Abilities:

• Demonstrated ability to work effectively both independently and as part of a team.
• 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 Practice, human subjects’ protections, and federal regulations related to clinical research

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.