Research Project Manager
Description - External
We are seeking a Clinical Research Project Manager to work in the Division of Alcohol, Drugs, and Addiction at McLean Hospital. The McLean Hospital Division of Alcohol, Drugs, and Addiction is a highly productive clinical research environment that has led and participated in landmark studies in the field. Under the direction of Roger Weiss, M.D., a PI of the New England Consortium Node of the NIDA Clinical Trials Network (CTN), we are currently leading a major multi-site CTN trial focused on treatment of opioid use disorder. We are looking for someone to help direct this and other projects at sites in our area. The candidate would also work with other investigators here on other clinical research trials in the area of addiction.
The primary task of the Clinical Research Project Manager for this group is to coordinate the work at the site in our area participating in the NIDA CTN study. This will involve working with research assistants, study medical clinicians, and interacting with members of the study lead team to successfully conduct the study at the local site. The Clinical Research Project Manager will be responsible for the oversight and coordination of this clinical trial site, including responsibility for ensuring the accuracy and integrity of collected data ana maintaining the highest levels of compliance with study regulatory protocols.
The Clinical Research Project Manager reports to the Principal Investigator and also works closely with the Research Project Director and follows established study policies and procedures per the study protocol. The Clinical Research Project Manager provides oversight of multi-center research studies and may be responsible for the following activities: developing agendas and presentations for meetings, providing oversight of research assistants who run study visits, assisting the department administrator with research financials, coordinating study participant recruitment and tracking efforts, on-boarding of new RA’s hiring/training and orientation to the department, coordinating community outreach activities, maintaining relationships with multiple internal and external study team members, and corresponding with the central study Clinical Coordinating Center (CCC) and Data and Statistics (DSC) .
McLean Hospital maintains the largest neuroscience and psychiatry research program of any private psychiatric hospital in the United States and was recently named the #1 Hospital in the country for psychiatric care by U.S. News and World Report.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Taking a major role in the direction of CTN studies within the New England Consortium Node
- Responsible for the coordination and implementation of research design process and study protocol at one or multiple sites, including regular communication with study staff regarding pertinent aspects of study progress, protocol implementation, participant recruitment and enrollment, data collection, and participant follow-up tracking, etc.
- Executes the procedural, managerial, and policy decisions made for the study at the study site.
- Participates in all decisions made for the study and the formulation and/or revision of policies and procedures. Identifies modifications needed to the study protocol and/or procedures and works to implement solutions.
- Responsible for proper and timely correspondence with study regulatory authorities (Mass General Brigham IRB, study single IRB (BRANY), central study Clinical Coordinating Center and Data & Statistics Center).
- Responsible for the oversight of all supplies, equipment, and files at the study site.
- Serves as the primary contact for outside vendors (study central Clinical Coordinating Center and Data & Statistics Center) utilized to ensure efficient operation of the study.
- Directly responds to inquiries regarding study protocol and policy. Serves as liaison to internal and external stakeholders.
- Collaborating with personnel around the CTN New England Consortium Node to coordinate meetings, address regulatory issues, develop and manage budgets in collaboration with the PI, Project Director, and the department administrator.
- Working with principal investigators leading trials to oversee operational aspects of studies on medication treatment for opioid use disorder and treatments for other substance use disorders (SUDs)
- Assisting in all aspects of project conduct (Budgets, IRB , staff management, data management, ensuring of quality, regulatory issue, study documentation, preparing of reports and manuscripts, etc.).
- Participates in writing grant proposals, preparing presentations and developing relevant manuscripts for publication.
- Has supervisory responsibility, in coordination with the PI and Project Director, for all study personnel, including hiring, firing, discipline, evaluation, orientation and training.
- All other duties as assigned.
Qualifications - External
Candidates should have a background in psychology, public health, pharmacology, medicine, or neuroscience and have experience with clinical trials research. Master’s degree in psychology, public health, pharmacology, or relevant social sciences (M.P.H., M.S.W., M.S./M.A.). Other requirements include:
- Strong project management skills.
- Strong computer skills.
- Excellent scientific writing and communication skills.
- Ability to track project milestones and ensure accomplishment of tasks and deliverables.
- Ability to travel to research sites and interact with site personnel and CTN researchers.
- Master’s Degree with a background in psychology, public health, pharmacology, other relevant social sciences, as well as experience with clinical trials research preferred.
McLean is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.