Technology Research Manager jobs in Minnesota

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 Program Manager I.

Position Description:

The Program Manager I is responsible for the day-to-day operations of multiple clinical trials. The

studies require an organized, motivated, skilled coordinator to monitor compliance and safety at each of

the trial sites in the study, to assess productivity, to provide technical and managerial support and

information for local sites to assure the successful progress and completion of these studies. The

National Study Coordinator will assist with setting up and managing approved clinical trials under the

supervision of the VA Principal Investigator.

Responsibilities: Major duties and responsibilities may include, but are not limited to the following:

Maintain close communication with the study leadership and staff, including project

managers at the coordinating centers, as well as the local VA site PIs.

Learn the rationale, structure, elements, clinical and regulatory elements of the applicable

clinical trials protocol.

Actively oversees and acts as a liaison between the entire study processes and study team.

Work collaboratively to facilitate study start-up, kickoff, accrual, follow-ups, close out and

analysis.

Training of site personnel on identifying potentially eligible subjects using electronic health

record searches

Ensuring all required VA trainings have been completed outside of the trial required trainings.

Presents and explains all study documents with each local site investigator and local study

coordinator to assure understanding and adherence to study procedures and appropriate and

correct data collection at each site.

Communicate with site coordinators, PI, the sponsor, VA and all study staff on FAQ’s and local

and national regulatory requirements.

Draft and disseminate study sources documents for participating sites’ electronic medical

records.

Oversee recruitment and help troubleshoot recruitment challenges and other VA sites.

Monitoring data queries and addressing timely corrections.

Completing and maintaining permissions for national VA data access

ICF and HIPAA documentation:

Adapting sponsors ICF’s and HIPAAs to ensure all VA required language is inserted.

Editing documents to for site-specific needs

Submitting site ICF’s and HIPAA documents to sponsor for expedite the process.

Work with site’s local regulatory staff to answer questions.

Coordination of commercial IRB submission under a single application:

Creating a projects shell in IRBNet and submitting all required documents for shell to be

approved

Providing instructions for all VA sites to open up their projects.

Preparing central IRB/BA and R&D correspondence and reports

Assisting with CRADA template dissemination

Assisting with site budget guidance

Working with sites local regulatory staff to answer questions when necessary.

Applicants must include a cover letter.

Minimum Qualifications:

Required Education: Bachelor’s Degree required in social science, healthcare, or business

field

Required Experience: 4 years’ experience with human subject research, including familiarity

with preparation and submission of IRB forms.

Preferred Experience: Experience working on federally funded projects.

Experience with the qualitative data software packages

Experience with reference management software

Experience with RedCap

Post-grad education (ie. Masters, PhD)

Licensure/Registration/Certification: None

Knowledge, Skills, and Abilities:

• Demonstrated ability to work effectively both independently and as part of a team.

• Familiarity with a range of clinical research methodologies and quality improvement, as well

experience running multi-site national studies is preferred.

• Familiarity with VA and/or military populations preferred.

• Ability to work as part of a large, multidisciplinary team and manage projects with strict

deadlines.

• Excellent oral and written communication skills needed to effectively work with multiple PI’s, co-

PI’s, study coordinators, and IRB officers.

• Exceptional attention to detail and organizational skills.

• Great time management skills with the ability to work on multiple projects simultaneously.

• 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.

Physical Requirements: The employee must be able to navigate the medical center, use a keyboard, and lift up to 25 lbs. Reasonable accommodation may be considered in determining an applicant’s ability to perform the duties/functions of the position.