BVARI is seeking a Project Manager to play a lead role in the establishment and execution of a multi-site clinical trial focused on testing whether atorvastatin, a cholesterol lowering drug, can lower the risk of frailty, a syndrome of aging and vulnerability. The Project Manager will plan, execute, and finalize projects and work products within the study Coordinating Center to implement and support approximately 20-30 study sites around the country. Reporting to the Principal Investigator, the Project Manager will assist with training and guiding the local Coordinating Center team as well as site teams across the country throughout the project's lifecycle. The Project Manager will also aid the study teams in adhering to strict deadlines and budget goals.
Duties and Responsibilities
Develop research plans and coordinate project operations overall.
Create and implement customized approaches to study site selection, on-boarding, and management.
Oversee the initiation and maintenance of the study's compliance documents and activities, including of Institutional Review Board (IRB) and Research and Development Committee (R&D) submissions and approvals.
Oversee and maintain study protocols, staff trainings, data access, and documentation.
Play a key role in coaching, mentoring, and developing study teams, both locally and at study sites nationwide.
Oversee permissions and authorizations for use of existing data sources.
Follow federal reporting requirements, including adherence to reporting deadlines.
Aid in manuscript preparation, report development, and presentations.
Draft budgets and recommend budgetary changes as necessary.
Manage project changes as needed, including identifying potential issues and devising and implementing appropriate contingency plans.
Build, develop, and grow business relationships vital to project's success.
Develop best practices tool for project execution and management.
Work with sites to develop and implement a process for tracking and reporting site enrollment and milestone achievements, and once certain thresholds for payment are achieved, relay any pertinent information to BVARI's finance team for payment.
Manage implementation of site payment terms, including compliance with the payment schedule, facilitating subaward amendments as needed, and otherwise ensuring that the Coordinating Center and Sites are working together as agreed.
Qualifications
5+ years of research project coordination experience, ideally including multi-center clinical trials.
Education and experience in public health or a related field.
In-depth knowledge of regulatory processes (IRB, Data Use Agreements, Material Transfer Agreements, etc.), study documentation development (Method of Procedure, Quality Assurance Manuals, Reporting Metrics, Communications Plans, etc.), and experience with a variety of digital data collection systems.
Familiarity with databases, forms technology, electronic data capture, reporting, data workflow, alerts, performance indicators, Sharepoint, Infopath, and Microsoft Office.
Ability and willingness to learn new software as needed.
Excellent communication skills (verbal and written).
Mastery of research infrastructure, critical problem solving, analytics, and juggling the coordination of multiple projects.
Expertise in forecasting potential problems and creating plans to counter those predicted.
Ability to stick to deadlines and help the study team achieve theirs.
Experience training personnel, creating study documents, and designing online trainings; ideally your experience is in study design, eligibility criteria, informed consent process, study protocol, informed consent forms, study operations manuals, and user guides.
Able to operate 100% confidentially and ensure compliance with study protocols, Good Clinical Practice standards, and the Health Research Protection Program (HRPP).
Ability to solve compliance issues effectively.
Must be willing to relocate to Massachusetts.
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. The employee must be a resident of Massachusetts upon the start date.
Selected 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.
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.
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 expected for this position.
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.