Project Manager

Boston VA Research Institute, Inc. (BVARI)- Project Manager

We are a Boston-based epidemiology and biomedical research organization. We are actively engaged in several clinical trials, pharmacoepidemiology, chronic disease epidemiology, genetic epidemiology, and -omics research. Our research team oversees study data related activities and quality improvement activities to improve the way translational research is conducted and clinical care is delivered. The multi-disciplinary center consists of a highly talented group of biomedical researchers, clinicians, epidemiologists, biostatisticians, data analysts/programmers, project coordinators, and informatics team with academic affiliations to Harvard Medical School and Boston University. We are looking for candidates with a service-oriented mentality, high sense of ownership of the assigned tasks and ability to solve problems presented by data.

GENERAL STATEMENT OF DUTIES AND RESPONSIBILITIES:

The hired Project Manager will work closely with VA Coordinating Center Lead Investigator(s) and will coordinate all aspects of multi-site clinical research projects within the VA Network. This role ensures regulatory compliance, effective communication, and successful project execution. The Project Manager will manage regulatory submissions, site support, training, documentation, and audit preparation, while providing leadership to project teams and junior staff. The Project Manager will also act as a key liaison between study sponsors, IRBs and the VA Coordinating Center, sharing insights on local activities to help with the development of network-wide professional education training, patient-facing educational materials, and good clinical practices.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The Project Manager will work closely with the PI to manage deliverables, oversee the maintenance of project study files, inclusive of Institutional Review Board (IRB) and Research and Development Committee (R&D) submissions and approvals, study protocols, data access and any documentation pertinent to the approved research for auditing purposes and oversee communication between study sponsors, and site investigators.

KEY RESPONSIBILITIES:

• Distribute model-approved regulatory documents to sites for local IRB submission and ensure compliance with protocol requirements.
• Delegate site management and Central IRB application support tasks to junior Project Managers, providing oversight and guidance.
• Coordinate and deliver comprehensive training on study protocols, regulatory documentation, and submission processes for site staff and Study Coordinators.
• Facilitate meetings with CIRB administrators, ISSOs, and Program Officers to resolve application-related issues and concerns.
• Serve as the primary contact for regulatory submission issues, providing timely resolutions for sites and the CIRB.
• Support sites in document revisions, responses to CIRB queries, and preparation for local and network-wide audits.
• Schedule and moderate site selection meetings, Site Initiation Visits, and track site status updates for sponsors.
• Manage and submit network and site IRB applications, amendments, continuing reviews, and ancillary study submissions.
• Oversee event reporting, including Unanticipated Problems (UAPs), protocol deviations, and other required notifications.
• Lead preparation for local Research Compliance Office (RCO) audits and ensure site compliance with IRB, VA, VHA, and other oversight committee regulations.
• Maintain and update regulatory support systems (e.g., BOX, DocuSign, SharePoint), sponsor vendor lists, and portfolio project tracking.
• Plan and schedule VA Network and Hub meetings; attend study committee meetings and present VA site updates.
• Prepare and contribute VA-specific content for sponsor-led meetings, newsletters, and the Manual of Procedures (MOP).
• Support site recruitment strategies, design network recruitment competitions, and collaborate on meeting agendas.
• Oversee contracts tracking, site payments, and resolve administrative issues with Nonprofit Corporations (NPCs).
• Serve as liaison between the Boston VA Research Institute, Inc. (BVARI) and staff for human resources (HR)-related issues.
• Provide administrative and regulatory support to the Principal Investigator (PI) and Project Management team.
• Determine the most appropriate communication workflows between self and participating providers and disseminate key program information and education to local team
• Serves as the primary liaison between the quality improvement program staff and clinical staff at the Boston VA to:
• Provide training to program site personnel on study projects with respect to clinical issues [program design, eligibility criteria, enrollment process, intervention strategies]
• Disseminate information about programs to local VA key stakeholders such as Service Chiefs, Pharmacy, and Administration to enhance and expand program reach and scope
• Ensure program teams maintain compliance with program protocols and Health Research Protection Program (HRPP) rules, policies, and procedures.
• Monitor site performance and ensure that program goals are met regarding expected performance levels
• Submit and receive proper approvals for program related activities such as patient education materials, creation of program specific medical record documentation, and changes to clinical processes or workflows
• Follow center standard operating procedures and demonstrate knowledge of and compliance with VHA Directives and Handbook Guidelines, Human Subjects Protections, and Good Clinical Practice standards
• Protect patient and scientific confidentiality by ensuring security of research data and protected health information
• Establish and guarantee effective and clear communication between operational teams on project specific issues.

QUALIFICATIONS AND ENTRANCE REQUIREMENTS:

• Masters-level education in scientific/clinical field required (e.g. Master of Public Health)
• 3 years of experience in research project coordination/ clinical trial management or work in healthcare setting preferred
• Have a good understanding of research and research infrastructure.
• Have or quickly gain an understanding of the following subjects: databases, forms technology, electronic data capture, reporting, data workflow, alerts, performance indicators, SharePoint, Microsoft Office.
• Professional writing, reporting and excellent communication skills.
• Effective analytical and problem-solving skills.
• Ability to work independently as well as part of a team in a fast-paced environment.
• Ability to adapt quickly to the changing demands of the organization.

The employee must be a resident of Massachusetts upon the start date.

Please note we are unable to provide work authorization and/or visa sponsorship.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

The physical demands described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee frequently is required to stand; walk; use hands; and reach with hands and arms.

Selective Service

If you are male application born after December 31, 1959, you must certify that you have registered with the Selective Service System or are exempt from having to do so under the Selective Service Law.

This position requires the ability to occasionally lift office products and supplies, up to 20 pounds.

Position Type/Expected Hours of Work

This is a full-time position, and hours of work and days are Monday through Friday, 8:30 a.m. to 5 p.m.

Travel

No travel is required for this position. Optional travel to scientific meetings may occur from time to time.

Work Authorization/Security Clearance

An employee in this position must complete all appropriate background checks at the time of hire and periodic reappointment.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Equal Opportunity Employer

Boston VA Research Institute provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfer, leaves of absences, compensation, and training.

Pay Range

Minimum $85,000.00, Midpoint $95,000, Maximum $105,000.00

Salary is based on related experience, expertise, and internal equity; generally, new hires can expect pay between the minimum and midpoint of the range.