Administrative Director, Neurosciences Clinical Trials Office

Reports To: Vice Chair, Department of Neurology, BWH and the Vice Chair, Department of Neurosurgery, BWH

General Summary / Overview Statement

The Administrative Director (AD) functions independently and under the direction of the Vice Chairs of Clinical Research for the Departments of Neurology (DON) and Neurosurgery (DONS). A hybrid position utilizing strong scientific skills while offering opportunities to work closely with all Divisions within the DON and DONS engaged in clinical trials. This is a senior level position with prior academic or industry experience in clinical research project management preferred. The AD responsible for all NCTO operations, regulatory, and project management services required to conduct clinical trials under FDA and institutional regulations. The AD will also contribute to the overall leadership and guidance of the entire NCTO towards achieving its mission to advance neurological care through excellence in clinical trials and to educate future research leaders in the field of neuroscience clinical trials. The AD must be able to communicate effectively with principal investigators, co-investigators, study nurses, data managers, and other members of the interdisciplinary team. The AD will provide project management advice to members of the DON/S and is expected to create new ideas, decide on workflow, work distribution, and have a senior leadership role in the NCTO. As a member of the NCTO organizational team, the AD shares the responsibility for providing the organizational direction necessary to effect change and promote excellence for the NCTO. The AD coordinates with NCTO leadership to ensure effective and optimum utilization of personnel, fiscal, and material resources.

Principal Duties and Responsibilities

Clinical Trials Management

• Oversees the clinical trials portfolio in the DON/S, maintains up to date database.
• Oversees and supervises all nursing professionals, clinical trial coordinators, clinical research assistants assigned to the NCTO.
• Provides on-boarding and ongoing training for NCTO personnel and study staff.
• Organizes, sets agenda, leads NCTO regular meetings.
• Organizes, sets agenda, supervises Site Initiation Visits (SIV) or study monitoring visits.
• Attends sponsor-organized meetings, as needed, for clinical trial projects.
• Interfaces with the FDA, NIH, DSMBs and IRBs both in oral presentations and with written reports.
• Liaises with DON/S Biospecimen Bank(s) for any clinical trial related biospecimen collections.
• Liaises with other departments (Radiology, Pathology, etc) involved as collaborating or co-investigators on neuroscience clinical trials.
• Oversees NCTO annual budget in collaboration with DON Executive Director and DON Finance Director.
• Negotiates clinical trial budgets with industry, federal, foundation sources in collaboration with clinical trial PI, Vice Chairs for Clinical Research.
• Works closely with Research Affairs on any grant submissions involving clinical trials.
• The AD will work closely with the Vice Chairs and PIs on new clinical trial submissions and annual progress reports, delivering within established timelines the required documentation to the institution/sponsor(s) in collaboration with all sites and personnel.
• The AD will establish strategic goals and objectives for neuroscience clinical trials program development, optimize project work cycles, establish operating guidelines. Manages and implements the clinical trial design process (including multi-site trials).
• The AD will be responsible for interactions with collaborators, leading collaborative projects through the process and assembling Annual Progress Reports.
• The position holds responsibility to train the NCTO future staff on new regulations, novel issues in study design, informed consent, confidentiality, data quality control, and other issues that arise with respect to the conduct of good clinical research practices. Provides expertise in Federal and hospital regulations.
• Will be a leader to execute plans in compliance with appropriate regulatory guidelines through start-up, implementation, and data analysis. The AD will have oversight responsibility for IRB submissions, amendments, and renewals.
• The position involves being a part of collaborative clinical trial project development with PIs, Co-PIs, collaborating co-investigators.
• The position holds a close working relationship with the Research Office on Pre- and Post- Award Management.

Human Resources

• Directs the operations of the NCTO Project Management Team. Has full line responsibility and accountability for management of personnel and fiscal resources.
• Train, supervise, and manage clinical research project managers and project management support staff in their responsibilities for all activities necessary to start, conduct, and close out multi-center clinical trials in the NCTO.
• Build and maintain ongoing working relationships with staff to facilitate positive staff morale and to support productivity through regular meeting.
• Responsible for daily supervision of Project Management Staff .
• Oversee day-to-day performance of administrative support staff.
• Assign and prioritize workload to administrative staff. 
• Ensures adequate administrative staffing to meet unit needs.
• Schedule and approve Earned Time.
• Implement corrective action as necessary.
• Assess staff competency and complete annual evaluation.
• Monitors staff adherence to regulatory requirements as well as hospital policies and procedures.

• Meets regularly with project management staff to organize and prioritize workflow.

Financial Management

• Works closely with DON and DONS Executive Directors and Finance Managers on individual trial budgets and overall NCTO budget.
• Assist with financial oversight of all network grants and subcontracts.
• Assist with financial oversight of NCTO grants and subcontracts.
• Assist with financial oversight and salary allocation/effort reporting for NCTO project management staff.
• Lead project management initiatives for operational efficiency to gain cost savings in clinical trials.

Qualifications

MS Required; Doctoral degree preferred

Clinical research and/or clinical trials experience preferred

Minimum of 5 years of progressively increasing levels of experience in a research-related field, preferably in the clinical trials domain. Prior supervisory experience required. Prior experience with financial management and data collection systems.

Skills / Abilities /  Competencies Required

Outstanding interpersonal and leadership skills

Strong analytical, statistical, and database skills

Understanding of clinical research and clinical trials procedures, practices, and regulations (Federal/Foundation/Industry)

Strong written and oral communication skills

Excellent time management skills

Strong organizational skills to formulate and complete vigorous timetables

Must possess the ability to make independent effective decisions in appropriate situations

Excellent judgment and ability to interpret information and protocol requirements

Demonstrated knowledge of Research Procedures and Practices (Federal/Non-Federal/Industry)

Good working knowledge of Microsoft Word, Excel, PowerPoint, Access, Teams are required 

Supervisory

Ability to Supervise others effectively. Responsible for the overall supervision of Study Staff including hiring, training, firing, evaluating and disciplinary actions.

Working Conditions

Busy office, clinical, and laboratory environment

Position requires flexible hours to meet established deadlines

Hospital Wide Responsibilities

Works within legal, regulatory, accreditation, and ethical practice standards relevant to the position and as established by BWH and Mass General Brigham; follows safe practices required for the position; complies with appropriate BWH and Mass General Brigham policies and procedures; fulfills any training required by BWH and/or Mass General Brigham, as appropriate; brings potential matters of non-compliance to the attending of the supervisors or other appropriate hospital staff.

EEO Statement 

Brigham and Women’s Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements, genetic information, military service, or other protected status.

For consideration, please send a statement of interest, one page maximum, and a CV to Jessica Kenyon, Executive Director at jkenyon1@bwh.harvard.edu.