Job description

VA Boston Healthcare System is looking for a Research Operations Manager to join our team.

The VA Research Program strives to promote Veteran-centered care to improve patient experiences and outcomes across VA healthcare and community settings, and to advance value-driven care by providing Veterans the highest quality care at the lowest financial burden.

The VA's research program is a field-based component of the Office of Research & Development (ORD) and strongly committed to supporting high quality, Veteran-oriented research across the entire spectrum, from basic research to clinical applications of new knowledge. Efforts will cover a broad range of scientific interests and focus on evidence-based care for informing clinical practice and enhancing health and health care for Veterans and the nation, through the support of the VA Cooperative Studies Program (CSP), the Network of Dedicated Enrollment Sites (NODES), and other VA ORD supported high impact research studies sponsored by other federally funded or industry trials.

The major duties include but are not limited to:

• Oversees day-to-day activities, operations and administration of clinical trial projects including the development, timely submission of all required documentation/ paperwork/forms for initial and continuing review of human subjects’ studies.

• Understands Protocols, Operation Manuals, and other research related materials, and evaluates day-to-day activities, operations and administration of clinical trials assigned.

• Monitors local study performance, project progress and timelines as required to ensure that data collection and transmission activities are compliant with applicable data security and privacy policies, required approvals and appropriate use of current study documents.

• Schedules meetings, including coordination of meeting space, notifying attendees, preparing the agenda and minutes and following-up on all commitments to ensure that necessary arrangements have been made.

• Directs the creation of research data logs, navigating existing VA databases, spreadsheets, and SharePoint for tracking data, budgets, and other protocol management responsibilities.

• Drafts detailed summary reports for presentation at meetings, conferences, publication in peer reviewed journals (if applicable).

• Provides technical guidance to research staff regarding regulations, policies, and procedures applicable to the conduct of research

• Participates in the interviewing process of candidates for CSP clinical trials, working with staff to ensure appropriate selection of study participants.

• Assists in the development of educational and training materials using nationally developed materials

• Facilitates CSP New Employee Orientation (NEO)/checklists for new study personnel.

• Assists in the development of policies and standard operating procedures.

• Participates in NODES/CSP national/program initiatives and meetings. Assists with local and national special projects/workgroups with stakeholders.

• Reports to the local NODES Leadership on success and challenges of study teams and individual personnel performance and provides interventional strategies as appropriate.

• Conveys findings and recommendations from study team members to VA research stakeholders that have an impact on the program objectives, work products and/or tasks.

• Ensures the development and timely submission (e.g., CIRB, R&D) of all required regulatory documentation (including paperwork/forms for initial and continuing review of human subjects studies).

• Develops tools for site teams to ensure quality assurance and regulatory compliance.

• Monitors data collection and protocols for difficult clinical research studies; provides site data integrity reports.

• Communicates assignments, projects, problems to be solved, actionable events, milestones, and/or program issues under review, and deadlines and time frames for completion.

• Monitors regulatory compliance including providing administrative support, maintaining study/regulatory files, reviewing electronic and/or hard copy documentation/data, and conducting performance oversight evaluations (e.g., pre-audits).

• Provides guidance and recommendations on appropriate research resources and support.

• Evaluates and helps establish efficient screening, recruitment, enrollment, and retention techniques for clinical research studies, and offers recommendations and tools to mitigate study barriers.

• Ensures that CSP study staff are trained and competent in recruitment, enrollment, and retention strategies of study participants, including screening techniques and follow-up visit engagement.

• Engages local CSP teams to ensure collaboration and enhancement of recruitment strategies.

• Coordinates completion of Site Feasibility Surveys to determine patient population data for prospective CSP trials.

• In collaboration with ADO, tracks NODES OKR metrics for targeted remediation of recruitment and enrollment challenges.

Job Type: Full-time

Pay: $64,251.00 - $77,738.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Jamaica Plain, MA 02130: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Clinical research: 1 year (Preferred)

Work Location: Hybrid remote in Jamaica Plain, MA 02130

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