Emp StatusRegular Full time
Work ShiftDay (United States of America)
Compensation RangeThe base pay scale for this position is $109,000.00 - $166,000.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.
What you will be doingRESPONSIBILITIES: Administrative: - Lead the development of strategic goals for the growth and development of the Sports Medicine clinical research program supporting their overall vision and mission.
- Coordinates the synchronization and management of research activities in the department under the direction of the Sports Medicine Research Chief. Analyzes, evaluates, and solves research problems and reports deviations where appropriate. Leads the improvement process as necessary.
- Provides oversight and supervision for all Sports Medicine research management staff as well as provides leadership, guidance, training and recognition for clinical research staff.
- Provide overall supervision and administrative direction for registry/clinical research activities. Provides timely reports to all applicable governing bodies: Director of the Executive Advisory Board, Institutional Review Board (IRB), Principal Investigator, National Institutes of Health and/or sponsor for each research project.
- Contributes to the recruitment process, oversees orientation, in-service training, and continuing education for Research Assistant (RA)/Clinical Research Coordinator (CRC) and Clinical Research Manager (CRM) staff and directs the workflow of employees, including delegation of responsibilities, establishing deadlines, scheduling, and project assignment.
- Manage all operational aspects of Sports Medicine research including staffing, budgets and timelines. Manage research teams, ensure strict regulatory compliance, and act as the primary liaison between investigators, sponsors, and stakeholders. Manages day-to-day operations of Sports Medicine research (e.g. handles I.T. communications/requests, generates study workflows/reports/tracking logs as needed, serves as the liaison between database development team and clinicians in order to build/revise the center's database, case report forms, and facilitates data collection) and is responsible for external reporting on patient reported outcomes as required by key stakeholders.
- Execute research priorities in alignment with departmental and institutional goals and report on research study enrollment performance and metrics to internal and external stakeholders. Develops and employs methods to continuously assess and improve division performance (weekly CRC/RA meetings, monthly project- specific RA/CRC/PI meetings).
- Will be responsible for budget development, contract execution, and milestone delivery for studies. Responsibilities include activities within the pre-award and post-award phases of study development.
- Manage, report, and support research related endeavors for internal and external reporting.
- Develop and promote a structure that will increase efficiency and streamline processes and create and implement policies and procedures to ensure operational standardization. Lead initiatives for operational efficiency, change management, and strategic process redesign to support continuous improvement and institutional excellence.
- Build and maintain a strong rapport with the Research Administrative and Clinical Research Administrative team and the office of the Chief Research Officer to support all research related activities of Sports Medicine and take proactive steps to avoid delays in study commencement.
- Serve as the liaison for principal investigators, providing guidance on protocol feasibility, submissions, compliance, and resource optimization; oversee IRB processes and the Scientific Review Committee (SRC) review coordination. Responsible for reviewing internal and external protocols for scientific merit and feasibility.
- Ability to model the core values and principles of Hospital for Special Surgery and serve as a role model for ethical research practice and departmental values, fostering collaboration and professional development within the research community.
Research: - Ensures that all research related regulatory, institutional and departmental compliance requirements are met as appropriate. Conducts internal audits of protocols. Ensures quality assurance (integrity of data) of projects. Facilitates completion of all internal documentation needed for IRB applications, conflict of interest forms, budgets etc.
- Communicates with potential collaborators, sponsors, and funding sources as needed.
- Establish and update standard operating procedures for Sports Medicine Research and ensure compliance with all internal and external requirements of regulatory agencies. Serve as key resource in annual Clinical Trial Audit.
- Manages data collection studies including but not limited to the performance of measurements for applicable studies, collection of clinical data from patients directly, and manage the performance of all other duties as put forth in the protocol. This includes the supervision of multidisciplinary teams involved in the successful conduct of the study as well as CRMs, CRCs and RAs assigned to independent research studies.
- Demonstrated commitment to training and mentoring junior team members and a collaborative research culture.
- Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of research data management.
MINIMUM JOB REQUIREMENTS:
Education/Training: - Master's degree required, PhD or MD preferred
Experience: - 7-10 years of experience in clinical research required with 3+ years in management
- Demonstrated clinical research management experience, ability to manage multiple projects and strong critical thinking skills
- Deep understanding of the drug/device approval process, IRB processes, and data privacy regulations (e.g., HIPAA).
- Knowledge of Good Clinical Practice and Good Technology Practice
- Proficient use of computers and Electronic Medical Records (EMR) and Electronic Data Capture (EDC) systems, including Epic and Redcap
- Experience in study design, analysis, grant writing, and publications
- Knowledge of statistical software preferred
Knowledge of Orthopedic and/or Rheu
