Clinical Research Project Manager II
The Palo Alto Veterans Institute for Research (PAVIR) is seeking a Clinical Research Project Manager position to serve as the Principal Investigator’s main point of contact for a multi-year funded study investigating the outcomes of extended release/long-acting opioids. This position will initially ramp-up the full project plan design, execution, and analysis of the study against the approved protocol, managing the day-to-day work flow against the project deadlines and ensuring the project is within budget.
This position will also be responsible for regulatory compliance and will coordinate with various audiences including but not limited to the VA, FDA, and other external stakeholders.
This is a regular, full time (40 hrs/wk), exempt position.
PAVIR is a nonprofit foundation affiliated with the Veterans Affairs Palo Alto Health Care System (VAPAHCS). As a condition of employment, all PAVIR employees are required to have an approved Without Compensation (WOC) appointment with VAPAHCS and complete a background check before they can commence work.
- Manage day-to-day communications of the study;
- Serve as the main point of contact for the study for various internal and external stakeholders;
- Organize and coordinate meetings with co-investigators and take minutes as needed;
- Serve as the liaison between multiple study sites;
- Update the PI on issues and concerns as needed;
- Manage day-to-day operations of the study from award to implementation;
- Establish project timelines and ensure study goals are accomplished;
- Organize and maintain system for tracking and scheduling all components of the study;
- Monitor study progress and identify and implement process improvements as needed;
- Anticipate project needs and address accordingly;
- Implement and execute action items from PI;
- Serve as a project lead and resource for other research staff;
- Oversee project management;
- Build cross-functional plans, manage budgets, initiate and coordinate resources, manage staff issues, as well as ensure timely delivery through a full project plan software development life cycle, including pre-launch and post-deployment research activities;
- Ensure regulatory compliance and other compliance matters for study;
- Serve as primary contact for sponsors for administrative and regulatory issues, and triage as appropriate; Research and prepare IRB and VA RDIS protocols;
- Ensure timely and accurate submission of local IRB submissions and coordinate responses to local IRB requests for additional information;
- Ensure compliance with protocol and research guidelines and requirements of regulatory agencies and HIPAA regulations;
- Assist in the determination of guidelines for the collection of clinical data or administration of clinical studies; Maintain, amend, and update regulatory documentation, including IRB and VAPAHCS compliance needs;
- Manage other administrative operations of the study;
- Assist with recruiting and hiring processes for other study personnel; Identify and acquire key resources in coordination with PAVIR and the VA (i.e. computers, software, office space, etc.);
- Coordinate data management of the study;
- Secure VINCI workspace and submit data use agreements;
- Oversee the compilation and documentation of clinical research data;
- Follow up and address data issues as needed;
- Other study related duties as needed.
EDUCATION: Minimum MA/MS degree (or equivalent experience) in a related field; Masters in Public Health or PhD in a related field desired;
LICENSE/CERTIFICATION: Clinical Study Certificate desired;
EXPERIENCE: 3-5 years of experience in a project management role within a research environment; Previous project management experience for a clinical research study desired;
- Strong knowledge and interest in clinical research and/or public health;
- Knowledge of VA and its health care system in regards to clinical research studies and understanding of VA procedures and safety issues highly desired;
- Knowledge of regulatory compliance with human subjects;
- Knowledge of IRB; Some knowledge of FDA and other sponsors desired;
- Knowledge with standard concepts, practices, and procedures within the research field;
- Strong organizational skills and project management skills;
- Demonstrated ability to work independently with minimal direction as well as cooperatively in a team environment;
- Proven capacity to set priorities, coordinate multiple assignments, and follow through within a fast paced, multi-tasked environment;
- Ability to build relationships and network with internal and external stakeholders to accomplish mutual goals;
- Ability to exercise sound judgment in setting priorities with a strong attention to detail;
- Ability to work effectively with a wide range of individuals and groups at all levels of authority;
- Ability to work with tact and sensitivity, especially in interactions with patients and other healthcare personnel;
- Excellent interpersonal, verbal, and written communication skills;
- Proficiency with Microsoft Word, Excel, and Outlook;
- Project planning software experience desired;
Environmental Conditions / Physical Demands:
Physical: Lifting up to 10 lbs. occasionally, standing, bending, repetitive movement, etc. May encounter subjects who are confused, agitated or abusive.
Environmental: Exposure to a clinical / office environment.
PAVIR engages in nonprofit medical research and works with sponsors and the Veterans Affairs Palo Alto Health Care System (VAPAHCS) in administering funds for conducting research to find new and improved ways to combat human disease and help people with disabilities. Please refer to our website for additional information: www.pavir.org
PAVIR is pleased to be an Equal Opportunity Employer for Minorities, Females, Protected Veterans, and Qualified Individuals with a Disability.