Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
Roles & Responsibilities:
The Clinical Research Manager (CRM) has oversight of the research projects within a department or division and will be responsible for the clinical trial delivery. CRM assists the Principal Investigator (P.I.) with the planning, management and reporting of trials in accordance with department plans/objectives, GCP, local requirements and department standard operating procedures. This includes facilitating, contracting, budgeting, regulatory submission, writing and/or reviewing protocols, site selection, start up, study conduct, data cleaning, data review and study close-out for one or more clinical trials.
- Develops, implements and evaluates standards of care of professional practice in collaboration with members of the health care team and in accordance with institutional policies and regulatory agencies requirements
- Collaborates with members of the health care team in program development, consultation, and the planning and delivery of optimal unit operations
- Manage all of the clinical operations activities from study start up to close out
- Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations
- Support study design. Review and/or writing of protocols, ICFs, etc.
- Contribute to the development of Case Report Forms
- Reviews and assists with the completion of regulatory packages for trial-related submissions to IRB/IECs
- Plan and/or conduct site evaluation, initiation routine monitoring visits
- Develop and maintain effective relationships with clinical study sites
- Plan and present at investigator meetings
- Act as primary contact for the CRO and other clinical vendors
- Review monitoring visit reports; liaise with monitors to understand any trends on data management issues or other site issues to develop solutions
- Provide oversight and accountability of all third party vendors
- Regular review of the Trial Master File (TMF) and ensure inspection readiness
- Manages human resources, includes of recruitment, hiring, evaluating, retention, discipline and termination
- Provide direction and support to the Clinical Operations study team, including Clinical Research Associates (CRA’s)
- Contributes to development of study budgets/contracts and ensures effectiveness of site budget /contract process
- Performs other related duties
- Education: Bachelor’s degree in sciences or related
- Experience: 5 years of experience in a hospital/medical environment
- 1 year supervisory
- 1 year in CRO, Pharma, Biotech or ARO preferred
Strength Through Diversity
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.