Clinical Research Project Manager II at Mount Sinai Hospital in New York, NY

Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

Roles & Responsibilities:

• Communicates project initiatives and tasks to team members and committee members clearly and regularly. Confers with staff (clinical team, research team, other project managers and admin staff) to outline work plan and to assign duties, responsibilities, and scope of authority. Responds to feedback and status reports from the project team and applicable committees and Directors to revise the project standard operating procedures, protocol, tasks and/or timeline as necessary.
• Oversees clinical, genomic, and other research data governance, sharing and communication, and regulatory compliance for IGH projects, including participating to several working groups organizing scientific conferences, training workshops, and presentations on project results; developing study protocol and standard operating procedures that are IRB compliant; managing research project budget; and data dissemination through federal data repositories.
• Participates to the submission of new IRB protocols, to the submission of project modifications and continuations, in coordination with other team members.
• Coordinates aspects of clinical utility assessment, cost analysis, and impact on health services and health policy in conjunction with administrators, providers, scientists, and stakeholders within the study and IGH.
• Helps in the preparation and submission of new scientific proposals and publications pertaining to clinical genomic sequencing, health policy, and genomic medicine.
• Ensures all staffing requirements and allotment of available resources to various phases of projects are met. May contribute to the performance evaluation of the employees associated with the project and may evaluate vendors and consultants and their effectiveness and ability to deliver as promised.
• Maintains effectiveness when experiencing major changes in work responsibilities or environment; adjusts effectively to work within new work structures, processes, requirements or cultures.
• Initiates and maintains strategic relationships with stakeholders inside and outside the health system (e.g. physicians, cross-functional partners, payers, suppliers, community representatives) to advance research, clinical and business goals.

Requirements:

• Master's degree in related field; A minimum of five years of experience in clinical research and regulatory compliance in developing countries; demonstrated ability to work successfully in these settings.
• Human Subjects Research Protections, working with the IRB, and FDA Regulatory requirements.
• Work with sponsors, industry, foundation, and federal to develop budgets, CTAs, and study startups.
• Extensive clinical trials experience.
• Proven track record of managing and training staff in a research setting.
• Well-organized in order to manage multiple projects, responsibilities, and competing demands simultaneously.

Strength Through Diversity

The Mount Sinai Health System believes that diversity and inclusion 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 healthcare delivery together.

We work hard to recruit and retain the best people, and to create a welcoming, nurturing work environment where you have the opportunity and support to develop professionally. We share the belief that all employees, regardless of job title or expertise, have an impact on quality patient care.

Explore more about this opportunity and how you can help us write a new chapter in our story!