Senior Clinical Research Associate - Tisch Cancer Institute

Mount Sinai Medical Center New York, NY
Strength Through Diversity

Ground breaking science.Advancing medicine. Healing made personal.

Roles & Responsibilities:

Thecandidate will be an integral member of the Cancer Clinical Trials Office(CCTO) Office within the Tisch Cancer Institute (TCI) of the Icahn School ofMedicine at Mount Sinai (ISMMS). The candidate is responsible for providingmanagerial oversight for TCI sponsored multicenter trials including protocoland informed consent form (ICF) development, site activations, data management,regulatory processing, monitoring, tracking specimen collection, data analysisand publication.

Thecandidate will manage the day-to-day operations of multicenter trials,coordination of study start-up, investigational product (IP) delivery, datamanagement, onsite and remote monitoring and other administrative functionsincluding weekly conference calls for the multi-institutional trials.

Thecandidate is responsible for implementing policies and procedures for themulticenter trials and will assist in the development of multicenter clinicaltrial budgets, sub-site invoicing/payment and help facilitate multicentertrials confidentiality disclosure agreements and clinical trial contracts.

Dutiesand Responsibilities:

* Leadthe coordination of investigator initiated multi-institution clinical trials.Clinical study life-cycle responsibilities include involvement in the selectionof sites, management of the training of study site personnel (includinginvestigators and coordinators), planning and oversight of study meetings, andmanagement/coordination of the day-to-day operational activities.

* Withinput from CCTO Senior Leadership, create and maintain Standard OperatingProcedures (SOPs) specific for each trial at participating sites.

* Assistwith developing consent forms, reviewing ICF changes made by participatingsites and assuring changes are compliant with ISMMS policies.

* Workwith PI to create data sets, including the selection of appropriate methods andtechniques to capture on case report forms in Electronic Data Capture Systems.Assist in the design and creation of protocol specific case report forms asneeded, prepares reports on individual patients or the study as required by theprincipal investigators and/or external agencies.

* ImplementPatient Central Registration policies and procedures to assure sites areenrolling patients that have met all eligibility criteria.

* Serveas central point person for program related matters and issues. Provideguidance on research-related questions within the program. Troubleshootpotential operational issues in complex oncology trials requiringmultidisciplinary setting and facilitates smooth clinical study operationsamong research team. Coordinate multi-institutional regulatory and datamanagement aspects of these investigator initiated trials (IITs).

* Serveas TCI CCTO contact for study activation and site initiation.

* Providetraining to multi-institutional sites for protocol and data entry. Ensuresubject data is entered in a timely fashion and perform routine monitoring ofsite data.

* Willingnessto travel about 20% of time to participating sites are within USA, mainly inNew York City.

* Workwith CCTO leadership to develop and implement strategies to build and grow theinvestigator initiated clinical research portfolio.

* Establishtimeline and target dates for completion of study milestones in collaborationwith trial leadership. Utilize data reports and site metrics to deliver milestoneson time and budget.

* Assureall clinical site trial documentation is maintained in compliance with allapplicable guidelines and corresponding procedures documents.

* Prepare,distribute, collect and archive all study related correspondence to theinvestigator clinical sites. Responsible for investigator recruitment and maintainingcurrent contact information for each assigned investigator site, as well aspreparing investigator site file for participation approval.

* Collectpre-study documentation and essential regulatory documents from assignedinvestigator sites as well as collect updated documents prior to study initiationand on an ongoing basis.

* Estimate,order and coordinate shipments of clinical study supplies to assignedinvestigator sites.

* Reviewand track all adverse events, protocol deviations, and any other unanticipatedproblems experienced by assigned investigator sites and communicate with assignedsites on routine matters.

* Performs other duties as required.


* Bachelor'sdegree / Master's degree preferred

* Minimum5 years experience in Phase I-IV clinical studies as a clinical researchassociate

* Experiencewith regulatory and data management aspects of clinical research

* Experiencewith budgeting and billing compliance aspects of clinical research

* Experiencein clinical research setting necessary, preferably with specific experiencemanaging multicenter investigator-initiated trials

* Experiencemanaging multi-site trials and participation in QA audits

* Proficiencyin MS Office, specifically word processing (Word), spreadsheets (Excel) anddatabase applications

* Excellentorganizational, oral and written communication skills

* Abilityto foster smooth communications and teamwork among clinical research faculty,fellows and staff as well as external sites and organizations (sponsors and contractresearch organizations)

* ExcellentCommunication and writing skills, professionalism and ability to effectivelyinteract with staff and management alike; ability to verbally communicateeffectively with management, department clinical research and other teammembers

Strength Through Diversity

The Mount Sinai Health Systembelieves that diversity is a driver for excellence. We share a common devotionto delivering exceptional patient care. Yet we're as diverse as the city wecall home- culturally, ethically, in outlook and lifestyle. When you join us,you become a part of Mount Sinai's unrivaled record of achievement, educationand advancement as we revolutionize medicine together.

We work hard to acquire andretain the best people, and to create a welcoming, nurturing work environmentwhere you can develop professionally. We share the belief that all employees,regardless of job title or expertise, can make an impact on quality patientcare.

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

Who We Are

Over 38,000 employees strong, themission of the Mount Sinai Health System is to provide compassionate patientcare with seamless coordination and to advance medicine through unrivalededucation, research, and outreach in the many diverse communities we serve.

Formed in September 2013, TheMount Sinai Health System combines the excellence of the Icahn School ofMedicine at Mount Sinai with seven premier hospital campuses, including MountSinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital,Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), MountSinai St. Luke's, and New York Eye and Ear Infirmary of Mount Sinai.

The Mount Sinai Health System isan equal opportunity employer. We promote recognition and respect forindividual and cultural differences, and we work to make our employees feelvalued and appreciated, whatever their race, gender, background, or sexualorientation.