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Senior Clinical Research Associate - Tisch Cancer Institute
Ground breaking science. Advancing medicine. Healing made personal.
The candidate will be an integral member of the Cancer Clinical Trials Office (CCTO) Office within the Tisch Cancer Institute (TCI) of the Icahn School of Medicine at Mount Sinai (ISMMS). The candidate is responsible for providing managerial oversight for TCI sponsored multicenter trials including protocol and informed consent form (ICF) development, site activations, data management, regulatory processing, monitoring, tracking specimen collection, data analysis and publication.
The candidate will manage the day-to-day operations of multicenter trials, coordination of study start-up, investigational product (IP) delivery, data management, onsite and remote monitoring and other administrative functions including weekly conference calls for the multi-institutional trials.
The candidate is responsible for implementing policies and procedures for the multicenter trials and will assist in the development of multicenter clinical trial budgets, sub-site invoicing/payment and help facilitate multicenter trials confidentiality disclosure agreements and clinical trial contracts.
Duties and Responsibilities:
- Lead the coordination of investigator initiated multi-institution clinical trials. Clinical study life-cycle responsibilities include involvement in the selection of sites, management of the training of study site personnel (including investigators and coordinators), planning and oversight of study meetings, and management/coordination of the day-to-day operational activities.
- With input from CCTO Senior Leadership, create and maintain Standard Operating Procedures (SOPs) specific for each trial at participating sites.
- Assist with developing consent forms, reviewing ICF changes made by participating sites and assuring changes are compliant with ISMMS policies.
- Work with PI to create data sets, including the selection of appropriate methods and techniques to capture on case report forms in Electronic Data Capture Systems. Assist in the design and creation of protocol specific case report forms as needed, prepares reports on individual patients or the study as required by the principal investigators and/or external agencies.
- Implement Patient Central Registration policies and procedures to assure sites are enrolling patients that have met all eligibility criteria.
- Serve as central point person for program related matters and issues. Provide guidance on research-related questions within the program. Troubleshoot potential operational issues in complex oncology trials requiring multidisciplinary setting and facilitates smooth clinical study operations among research team. Coordinate multi-institutional regulatory and data management aspects of these investigator initiated trials (IITs).
- Serve as TCI CCTO contact for study activation and site initiation.
- Provide training to multi-institutional sites for protocol and data entry. Ensure subject data is entered in a timely fashion and perform routine monitoring of site data.
- Willingness to travel about 20% of time to participating sites are within USA, mainly in New York City.
- Work with CCTO leadership to develop and implement strategies to build and grow the investigator initiated clinical research portfolio.
- Establish timeline and target dates for completion of study milestones in collaboration with trial leadership. Utilize data reports and site metrics to deliver milestones on time and budget.
- Assure all clinical site trial documentation is maintained in compliance with all applicable guidelines and corresponding procedures documents.
- Prepare, distribute, collect and archive all study related correspondence to the investigator clinical sites. Responsible for investigator recruitment and maintaining current contact information for each assigned investigator site, as well as preparing investigator site file for participation approval.
- Collect pre-study documentation and essential regulatory documents from assigned investigator sites as well as collect updated documents prior to study initiation and on an ongoing basis.
- Estimate, order and coordinate shipments of clinical study supplies to assigned investigator sites.
- Review and track all adverse events, protocol deviations, and any other unanticipated problems experienced by assigned investigator sites and communicate with assigned sites on routine matters.
- Performs other duties as required.
- Bachelor's degree / Master’s degree preferred
- Minimum 5 years experience in Phase I-IV clinical studies as a clinical research associate
- Experience with regulatory and data management aspects of clinical research
- Experience with budgeting and billing compliance aspects of clinical research
- Experience in clinical research setting necessary, preferably with specific experience managing multicenter investigator-initiated trials
- Experience managing multi-site trials and participation in QA audits
- Proficiency in MS Office, specifically word processing (Word), spreadsheets (Excel) and database applications
- Excellent organizational, oral and written communication skills
- Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external sites and organizations (sponsors and contract research organizations)
- Excellent Communication and writing skills, professionalism and ability to effectively interact with staff and management alike; ability to verbally communicate effectively with management, department clinical research and other team members
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.