Ground breaking science. Advancing medicine. Healing made personal.
The position is responsible for the supervision and coordination of assigned administrative and general office activities consistent with departmental objectives, administrative policies and practices. Provides direct supervision for administrative and office support staff such as secretarial/administrative assistants, medical assistants, schedulers, data management and medical records staff. Ensures the successful delivery of support services within the department or unit. Assumes responsibility of higher (managerial) leadership for department as required.
Duties and Responsibilities:
- For designated employees, make recommendations regarding hiring/firing and participate in these processes; conduct QA assessments of work outcomes; conduct performance evaluations, manage PTO and other administrative human resource tasks as assigned, provide mentorship and disciplinary action when warranted.
- Supervise Full Board IRB Analyst I teams by recruiting, orienting, and assist in training employees; maintaining a safe, secure, and legal work environment; Ensures compliance with federal, state and local regulations regarding equal pay and equal employment.
- Understands and applies the Federal Regulations for human research to project applications submitted for category determination and each level of IRB review (pre-review, re-review, clarifying issues, post meeting, Non-committee review) to ensure adherence to regulatory and ethical standards.
- Assess level of review needed to process work assigned to staff.
- Assign daily/weekly project assignments/distribution of work to team(s) weekly or as needed.
- Participates in the quality assurance review of analyst work and assists in resolving related issues.
- Independently reviews an average of 150 projects annually.
- Serves as an IRB member, attends Board meetings, facilitates resolution of controverted issues, and assists in the preparation of minutes and post-meeting communication with researchers.
- Conceptualizes and can formulate the complexity of a project and provide guidance on next steps while integrating the PPHS Program’s values and objectives with the overall objective of making the process easier for processing.
- Consults on project development and design, consent processes, and data storage solutions to facilitate quality science in the construct of the Federal Regulations and Institutional policies.
- Conceptualizes the steps necessary for final resolution of work/projects and follows through with appropriate steps to deliver final project approval/determination within office metric requirements.
- Serves as a resource on general regulatory information and provides guidance about forms and submission procedures and prioritizing work.
- Provides expertise for development of staff and IRB members; prepares and teaches departmental in-services and assists with educational presentations to the research community.
- Serves as a resource in making project regulatory determinations and may make final determinations.
- Actively engages in the negotiation resolution of researcher complaints and solves problems/issues in a timely manner.
- Maintains documentation and records in accordance with departmental policies and procedures and ensures that all records are secured and properly archived.
- Maintains computerized database for tracking purposes. Enter or update database for complete submissions to PPHS.
- Composes and distributes correspondence to investigators on behalf of the Board, Directors, or Chairs.
- Must have a strong understanding of Institutional policies and strong working knowledge of PPHS SOPS to assess status of projects due for submission renewals. May negotiate with research teams on timing of submissions.
- Assess status of projects where research teams have failed to submit required paperwork (continuation/emergency use, etc.). Require notifying other Research Administrative offices of expirations and possible non-compliance.
- Oversees the monitoring of quorum at IRB meetings, tracks IRB attendance, and oversees the preparation of meeting minutes of all action plans and discussions.
- Performs other related duties.
The Mount Sinai Health System believes that diversity is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize medicine together.
We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care.
Explore more about this opportunity and how you can help us write a new chapter in our story!
Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.