JOB DESCRIPTION

The Clinical Research Associate is an integral part of the research study team and monitors all safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for collecting, assessing and processing Adverse Events (SAE) for safety reporting, CEC and DSMB of clinical studies to ensure compliance with regulations and guidelines. The CRA also collects, maintains and organizes study information.

RESPONSIBILITIES

Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB):

• Synthesizes information from various sources as it pertains to the safety of all patients enrolled in a study in accordance with study protocols and compliance with governmental/health authority regulations. Adheres to the different specific trial protocols and charters.

• Provides reports and statistics related to dissemination of safety information to the Clinical Trial Management team members and clinical trial core team members, as appropriate.

• Monitors timelines for adverse event processing, reviews summary safety data at regular intervals f and monitors CEC adjudication results.

• Develops familiarity with various EDC, flowcharts; monitoring guidelines; statement of work and SOPs; Core Laboratories, other vendors, and CROs; etc.).

• Receives initial and follow-up AEs reports and case report forms via electronic data capture systems or secure share point platform and processes these.

• Maintains AE data collection and documentation as per SOP including entering adverse event data into various safety databases.

• Participates in or is responsible for reconciliation of drug safety databases and clinical study databases for adverse event reporting and tally. This includes evaluating clinical database for non-site reported adverse events and their follow-up.

• Recognizes missing/ incorrect data and initiate missing data queries/data clarification queries to clinical sites regarding adverse events.

• Requests appropriate source documentation necessary to analyze adverse event for seriousness and causality.

• Prepares narratives of adverse events reported by principal investigators participating in clinical studies sponsored or managed by Icahn School of Medicine at Mt Sinai for adjudication by the CEC.

• Participates with the Associate Director of Research and Quality Outcomes in the preparation, attendance and hosting of CEC and DSMB meetings on an established schedule, providing agenda, recording/reviewing and distributing of minutes to Associate Director of Research and Quality Outcomes, CEC/DSMB Chair and sponsors.

• Prepares, collects and archives all study related correspondence with the investigative sites and sponsor including, but not limited to associated correspondence, CEC and DSMB members CVs, medical license, COI and NDA, contractual agreements, invoices and others.

• Collects, reviews and files all clinical study documentation for assigned trial(s) and investigative sites and maintains the clinical trial master file (CTMF): assures all documentation is maintained in compliance with all applicable guidelines and corresponding Mount Sinai SOPs.

• Assists the Associate Director of Research and Quality Outcomes compiling and tracking CEC/DSMB deliverables for invoicing to ensure contract milestones are recognized and presented to sponsor for payment in accordance with the approved study budget.

• Assists in the development and review of the corrective action plans as requested during internal/external audits and implements plans as required.

• Additional duties as assigned.

Safety Reporting:

• Assists the Associate Director of Research and Quality Outcomes with reporting of adverse events, protocol deviations, and any other unusual activity in keeping with the defined endpoints of the trial charters and may communicate with sponsor and CROs on a regular basis.

• Reviews adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable.

• Reports safety findings in a summary format to the Associate Director of Research and Quality Outcomes.

• Interfaces with project management, functional team members and investigators to ensure a timely and precise safety reporting process.

• Assists in preparing clinical study reports of assigned projects for submission to regulatory authorities.

QUALIFICATIONS

Education:

• Bachelors Degree in life sciences or Foreign M.D or D.O. or BSN

Experience:

• 3 years of experience in Phase I-IV clinical studies as a clinical trial assistant or clinical research associate is required.

• 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.

Non-Bargaining Unit, 821 - Cardiology - ISM, Icahn School of Medicine

REQUIRED SKILLS

MS Excel

MS Word

Microsoft Access

Outlook

ABOUT US

Strength Through Diversity

The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. 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 invite you to participate actively as a part of the Mount Sinai Health System team by:

• Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.

• Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.

• Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.

At Mount Sinai, our leaders strive to learn, empower others, and embrace change to further advance equity and improve the well-being of staff, patients, and the organization. We expect our leaders to embrace anti-racism, create a collaborative and respectful environment, and constructively disrupt the status quo to improve the system and enhance care for our patients. We work hard to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to advance professionally.

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

About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time -- discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes approximately 7,400 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 14 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression. We are passionately committed to addressing racism and its effects on our faculty, staff, students, trainees, patients, visitors, and the communities we serve. Our goal is for Mount Sinai to become an anti-racist health care and learning institution that intentionally addresses structural racism."

EOE Minorities/Women/Disabled/Veterans

Requisition ID : 3006614