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The Clinical Research Associate monitors all aspects of clinical research trial(s) and performs analytic activities involved in the planning, conduct and completion of a clinical trial(s). Clinical study life-cycle responsibilities including site selection and start-up, site management, ongoing maintenance and closure of pre-clinical, Phase I through Phase IV, and post-marketing studies
- Contribute to the development of critical study documents including (e.g. protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; statement of work laboratory, other vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.)
- Participate with the clinical trial management team in establishing timeline and target dates for completion of study milestones and use analytical and monitoring resources/reports to deliver milestones on time and budget
- Serve as primary contact for CROs/vendors, Investigators and study coordinators for study related questions
- Collect, review and file all clinical study documentation for assigned trial(s) and investigative sites and maintenance of clinical trial master file (CTMF): assure all documentation is maintained in compliance with all applicable guidelines, corresponding SOPs and checks for consistency with the contents of sponsor files
- Work with the Clinical Trial Manager (CTM) and all applicable parties to conduct site feasibility checks, design and implement training to site personnel and assess trial sites and applicable personnel on an ongoing basis. Perform site selection, initiation, monitoring and close-out visits, plus maintain appropriate documentation
- Participate with the CTM in the preparation and hosting of global clinical study team meetings on an established schedule, providing agenda, recording/distributing of minutes and copying of minutes to CTM
- Work with the CTM to prepare and compile materials for clinical study conduct and reference information for study sites provided to the site in the form of an investigator site file (ISF)
- Support the development of a subject recruitment plan to increase patient randomization into the trial (i.e. facilitate International investigator and research staff meetings, draft and distribute newsletters, draft patient recruitment letters and reminders to participating sites)
- Estimate, order and coordinate shipments of clinical study supplies and study drug/treatment as applicable to participating investigator sites
- Work with CTM and Finance to ensure payment for sites and vendor services as requested
- Monitor site quality and performance on a routine basis. Ensure independent monitoring of clinical studies documents all findings, outcomes, and agreements reached during site visits by field monitors. Manage clinical studies according to timeline; ensure sites track and report all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites and communicates with assigned sites on routine matters
- Report safety findings in a summary format to the CTM and Lead Investigator as needed
- Prepare documentation for and attend Clinical Event Committee (CEC) meetings, if applicable
- Independently or in collaboration with CRO vendor, identify and documents data errors or items requiring clarification on all documents collected for study and initiates data clarification/validation process after researching source documents
- Assist in preparing clinical reports of assigned projects for submission to regulatory authorities
- Perform other duties as required
- Education: Bachelor’s Degree in life sciences OR B.S.N. Nursing degree
- Experience: A minimum of 2 years of experience in Phase I-IV clinical studies as a clinical trial assistant or clinical research associate is required.
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.
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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.