Director, Research Operations, Department of OBGYN - Boston, MA, United States - Boston Medical Center

Description

Director, Research Operations, Department of OBGYN page is loaded

Director, Research Operations, Department of OBGYN

POSITION SUMMARY:

Under the general direction of the Department Chair and the Vice Chair of Academics, the Director plans, directs, coordinates, and implements all funded and unfunded research projects that take place in the Department of Obstetrics and Gynecology at Boston Medical Center. The focus of this position is to support the overall research mission of the department, by working to increase grant funding (and maintain existing funding), facilitate the successful implementation and maintenance of ongoing research activities, enhance department-wide efficiencies, and promote an informed and collaborative work environment for faculty and staff.

The Director of Research Operations will achieve these goals by collaborating with the Vice Chair of Academics on strategies to successfully complete grant writing and submissions, oversee study protocol development and implementation, negotiate contracts with external organizations, provide fiscal and data management oversight, facilitate publications, complete routine reporting to local and federal agencies, liaison with Institutional Review Boards, Human Resources, and Grants Administration, and oversee personnel management. The ideal candidate will have extensive clinical and health services research and operations experience, affording the ability to advise, implement, oversee, and strategize to optimize research funding and productivity.

Position: Director, Research Operations

Department: OBGYN

Schedule: Full Time

ESSENTIAL RESPONSIBILITIES / DUTIES:

Primary Responsibilities:

• Reviews, evaluates, and seeks to initiate new studies in cooperation with the faculty in the department and other departments, as appropriate.
• Partner with faculty, the BUMC/BMC IRB and BMC Clinical Trials Office to plan, direct, and oversee the conduct of all OB/GYN protocols.
• Collaborate with Grants Administration to ensure grants are administratively approved by Boston Medical Center and Boston University and compliant with federal and institutional policies. Initiate and oversee Memorandums of Agreement (MOA) with subcontract agencies.
• Oversees all grant and contract budgets with funding entities including local, state, federal agencies, and other external funding agencies. Track monthly and annual spending across multiple budgets, project carryover, anticipate shortfall and adjust spending as necessary. Develop budgets for new grant applications and annual progress reports. Negotiate subcontract and consultant budgets. Review and approve all subcontract invoices. Oversee multiple subcontracts with collaborating institutions.
• Responsible for interface with funding agencies, administration of funded programs and fiscal oversight. Acts as liaison to other BMC departments and services for multidisciplinary studies and programs.
• Establishes and maintains effective working relationships between all departments working collaboratively with OB/GYN.
• Assures all BMC/BU, City, State and Federal guidelines are followed pertaining to the clinical and ethical responsibilities of all studies conducted in the Department of OB/GYN
• Maintains compliance with FDA and/or any other regulatory commission standards.
• Hire and supervise staff (e.g., Research Assistants, Coordinators, Managers), including training, delegating tasks, overseeing daily activities, offering opportunities for professional development, and evaluating performance
• Establish and maintain Standard Operating Procedures (SOP) for departmental research.
• Create and maintain department research websites.
• Lead monthly research steering committee meetings.
• Oversee the department SEED grant program including communication with the department, application review, assigning of reviewers, overseeing use of funds, and obtaining required reports from researchers.

Specifics Duties relevant to each Area:

Research Development, Implementation, & Maintenance

• Participate in the development of research study protocols
• Play a lead role with the Principal Investigator (PI) and Co-investigators in the development and writing of grant applications, including complex, multi-component NIH funding mechanisms (e.g., Centers and Consortia).
• Strategize with the Vice Chair of Academics on the timing of grants submissions and identification of research collaborators.
• Works directly with faculty and PIs and guides them through appropriate documentation and approvals with the IRB, modifications, amendments, continuing review and close out reports.
• Assure that all PIs and study staff have appropriate certification in the Protection of Human Research Subjects and Good Clinical Practice Guidelines
• Oversees clinical research databases, including statistical and other data collection, analysis, and reporting for grant-funded contracts and for other clinical care and clinical research programs.
• Oversees the maintenance and storage of all study documentation (paper and electronically) per BMC/BU IRB, sponsor, and federal guidelines.
• Coordinate with grant managers outside of the department who manage OB/GYN research grants and salary support (in Pediatrics, with the Health Equity Accelerator, Grayken, etc.)
• Ensures completion of mandatory reports to funding agencies.
• Organizes faculty, residents, and research study teams to submit abstracts, edit presentations, and write and submit scientific papers for publication; participates as author.
• Provide guidance to junior faculty, and other trainees on issues related to research development, IRB regulations, manuscript and presentations, and BMC/BU and NIH guidelines related to conducting research.
• Serve as liaison to the Clinical Data Warehouse.
• Develop and maintain relationships with collaborators to form new research opportunities
• Contribute as a co-author on peer-reviewed manuscripts of research results; i.e., participate in the development of the research question, interpretation of results, review of background literature, and writing text.

Personnel Management

• Manages initial and ongoing training of all research staff members.
• Coordinate onboarding of new research staff.
• Ensure staff competency in all clinical and data platforms (Epic, QPath, Info Ed, Infor, Clin Cards, Velos, WebDCU, RedCAP, Qualtrix etc.).
• Establishes objectives with all staff members on the research team; determine standards of performance; evaluates subordinates' performance and ensures that individual staff members are meeting objectives.
• Coordinate students and volunteers on departmental research projects, including position posting, interviews, elective evaluations, and stipends when appropriate.
• Ensure cohesion within and across teams.
• Assist department faculty with hiring, training, and evaluating research personnel.
• Oversee Managers to facilitate the implementation of research studies, ensure proper reporting, personnel management, and fiscal oversight
• Investigates and responds appropriately to any and all study or staff related complaints and takes effective corrective action when necessary. Demonstrates the ability to identify and resolve interpersonal or professional conflicts when dealing with members of the organization.
• Responsible for the effective human resource management of research staff within the department.
• Works with the HR Business Partner or appropriate supervisor/Director to resolve any salary, benefit or human resources related problems.
• Effectively works with Human Resources at BMC and the BU Student Employment Office to resolve issues in a timely fashion.
• Works directly with Human Resources to post new positions, hire, discipline, and terminate employees as needed.
• Manage weekly BMC research staff time approval for payroll.
• Ensure BMC research staff compliance with annual trainings.
• Strategize with the Vice Chair of Academics regarding personnel effort/resources (i.e., redistribute personnel effort when teams are over/under staffed based on skillset of employees and needs of project).

Administrative Management

• Works directly with Grants Administration and all Research Compliance teams at BMC to ensure grants are administratively approved by Boston Medical Center/Boston University and compliant with federal and institutional policies.
• Helps PIs complete and review Confidentiality Disclosure Agreements (CDA) and Data Usage Agreements (DUA).
• Develop budgets for new grant applications and annual progress reports.
• Negotiate subcontract and consultant budgets
• Manages research grants, budgets, and payroll.
• Track annual spending across multiple budgets, project carryover, anticipate shortfall and adjust spending as necessary.
• Manage BMC effort reporting and BU SAP cost distribution changes for grant/contract-funded faculty.
• Complete and submit periodic Personnel Activity Reports (PAR) for all faculty engaged in research.
• Develop, enhance, and implement processes, procedures, and systems to facilitate research by faculty through:
• Production of tools and templates for budget development, study feasibility, and compliance with regulatory requirements and organizational policy.
• Identification and development of improved procedures, systems, and policies, including development of database tools and other sources of information that support investigators' research initiatives.
• Establishment of internal monitoring programs to measure the accuracy of the administrative processes supporting the research activities.
• Performs consistency checks, error edits, and monitors timeliness of data submission to sponsors.
• Oversee NIH and state reporting (e.g., progress and final reports)
• Serve as a liaison with NIH Program Officials

JOB REQUIREMENTS

EDUCATION:

• Requires doctoral degree (PhD or DrPH)

EXPERIENCE:

• Requires at least 7-10 years of research administration and management experience.
• Experience with proposal preparation and team leadership skills.

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