Research Project Director (Non-Competitive) bei New York State Psychiatry Institute

Job Title: Research Project Director (Non-Competitive)

Grade: 31

Salary: $124,295-$145,000

The Research Foundation for Mental Hygiene is seeking a qualified candidate to fill a full-time Research Project Director position for the Translational Epidemiology department.

The Senior Program Manager will help develop, coordinate, and operationally lead the Mood Disorders Research Program (MDRP) at Brigham & Women's Hospital.

MDRP is focused on identifying persistent cognitive deficits in major psychiatric disorders, understanding their etiologies, and directly targeting them with treatment. Primary ongoing studies in patients with bipolar disorder and depression focus on neurocognition and social cognition and their relationship with everyday functioning. We incorporate a wide range of potential predictors of outcome including sleep quality, childhood trauma, inflammatory markers, and genetics in an effort to characterize the heterogeneity in cognitive and functional outcome that is seen in these disorders. We are also actively pursuing potential treatments focused on improving cognition in patients with serious mental illness.

Under the direction of Dr. Katherine Burdick, the Senior Program Manager is responsible for overall program management and operational leadership of the program and oversees program staff.

This role includes direct supervision of three research assistants (with a plan to hire up to an additional four), a project coordinator, a to-be-hired database manager, an administrative assistant, junior faculty affiliated with the program, research fellows and trainees. This is a senior level position with prior academic or industry experience in clinical research or project management and conduct of clinical research. The incumbent will establish strategic goals and objectives for program development, optimize project work cycles, optimize standard operating procedures, develop and implement policies for clinical research conduct, provide expertise in federal and hospital regulations, supervise research assistants and other study staff, and will be the source of training, education, and knowledge on clinical trial conduct for the program. The Senior Program Manager will train staff and team members on new regulations, novel issues in study design, ethics, informed consent, confidentiality, sample and data quality control, and other issues that arise with respect to the conduct of good clinical research. The Senior Program Manager will have full responsibility for IRB amendments and renewals and will liaise with other clinical research units at Mass General Brigham. The Senior Program Manager will also be responsible for interaction with collaborators, leading collaborative projects through the process, and act as a liaison with funding agencies (federal, foundation, pharma).

Duties and Responsibilities:

• Administratively support Dr. Burdick in her role as co-chair of the Milken BD

Initiative.

• Primary involvement in managing 6 domestic sites for a large scale (n=4000) 5+ year
• longitudinal study of bipolar disorder. Likely to broaden to international sites after year 1 of the project.
• Aspects of management may include conducting site surveys, training site staff, monitoring, drafting SOPs, liaising with biorepository, clinical and data cores, and participant outreach.
• All other duties as prescribed by Dr. Burdick and the Milken Institute.
• Develop and maintain standard operation procedures for the conduct of clinical studies within the program per scientific, IRB and FDA guidelines.
• Serve as primary resource for all regulatory and operational aspects of program projects.
• Conduct IRB amendments, IRB continuing reviews, IRB reports, maintaining IRB folder including logs of meetings, CVs, lab certifications, MD license documentations, adverse events.
• Build project plans, and lead study teams to execute plan in compliance with appropriate
• regulatory guidelines through startup, implementation, and data analysis.
• Serve as operations leader for all projects supporting the program and ensuring that
• operational tasks are consistently executed.
• Train and supervise staff on the conduct of clinical research.
• Interface with collaborators and lead collaborative projects with the PI.
• Design and launch new clinical research studies, including virtual research visits, utilizing videoconferencing tools and electronic data capture.
• Will supervise all personnel of the Mood Disorders Research Program.
• Will be responsible for managing the program budget in conjunction with departmental research administrators.
• Develop and manage website for the Mood Disorders Research Program.
• Execute Materials Transfer, Non-Disclosure, Data Use, and other agreements.
• Recruit, interview, onboard, and evaluate staff hires.
• Maintain budgets for projects within the program.
• Assist with grant writing.
• Interact with funding and regulatory agencies.
• Update and improve existing infrastructure for the program (e.g. update case report forms and
• other study-relevant documents, database development, biospecimen management, establish data flow/safety monitoring processes, etc).
• Establish standard best practices for (i) clinical study visits, (ii) sample processing, (ii) data processing, (iv) sample storage and tracking.
• Update standard operating protocols, CRFs, and study protocol.
• Mentor and assist staff on all issues related to clinical research.
• Analyze data and prepare reports for publication.
• Conduct ongoing quality assurance audits to ensure research activities comply with applicable regulatory policies.
• Conduct structured psychiatric assessments.
• Accept responsibilities for special projects as required.
• Accept temporary fill-in responsibilities for all jobs as required and as capable (i.e. when the PI is off site, when a research assistant is on sick leave, during freezer emergency, etc.).
• All other research and administrative duties as assigned by principal investigator.

Minimum Qualifications:

• Master's degree required.
• Minimum of (7) years of progressively more responsible experience in a research related field. Prior supervisory experience required.
• Prior experience with financial management and data collection systems.
• Excellent knowledge of IRB regulations regarding human subjects and clinical research is mandatory.
• Previous experience in conducting clinical trials, clinical biomarker studies, or human genetics studies is strongly recommended.
• Experience with REDCap or similar online research instruments is beneficial.

Preferred Qualifications:

• Understanding of clinical research methodology and regulations. Project management and leadership skills, good presentation and writing skills are required.
• Ability to take responsibility, reliability, exemplary work ethic, and precise implementation are required. We are looking for a person who is fully focused and dedicated to the success of MDRP
• Ability to continuously anticipate and identify any potential issues that can be improved AND to immediately take responsibility to find and implement workable solutions AND to follow-through and verify the problem resolutions.
• The Senior Project Manager is expected to take ownership stake in the program and, if necessary, to go above and beyond her/his duties in order to make the study a success. If other team members cannot adequately take care of an issue, the Senior Program Manager will be expected to step in and temporarily take on additional duties as needed for the program's continued success.
• Ability to lead by example, through motivation and encouragement
• Ability to interact well with others, take initiative, and think independently required.

Work Location: 1051 Riverside Drive, New York, NY 10032

To Apply: Submit an application through our website at https://rfmh.applicantpro.com/jobs/. Please note only applications submitted through our website will be considered.

The Mission of the Research Foundation for Mental Hygiene, Inc. (RFMH) is to promote the mental health of all New Yorkers, with a focus on providing hope and supporting recovery for adults with serious mental illness and children with serious emotional disturbances. Applicants with lived mental health experience are encouraged to apply. RFMH is deeply committed to supporting underserved individuals, organizations, and communities. To this end, RFMH is focused on implementing activities and initiatives to reduce disparities in access, quality, and treatment outcomes for underserved populations. A critical component of these efforts is ensuring that RFMH is a diverse and inclusive workplace where all employees' unique attributes and skills are valued and utilized to support the mission of the Agency. RFMH is an equal opportunity/affirmative action employer.

The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees, do not participate in any state retirement system, and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action/Equal Opportunity Employer - Disabled/Veteran, 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a) compliant.