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

• Supports ongoing clinical studies through review of medical safety databases; creating narrative reports for notable clinical events;

• Responsible for receiving initial and follow-up adverse events (AEs) reports via case report forms and/or electronic data capture.

• Maintains AE data collection and documentation as per Icahn School of Medicine at Mt Sinai SOP including entering adverse event data into safety databases.

• Recognizes missing / incorrect data and initiates missing data queries / data clarification queries regarding adverse events.

• Requests appropriate source documentation to analyze adverse event for seriousness and causality and prepares narratives for and assists in the presentation of cases for adjudication by the CEC.

• Responsible for tracking AEs, monitoring timelines for event processing, reviewing summary safety data at regular intervals, and monitoring adjudication results of the Clinical Events Committee (CEC) or Clinical Safety Monitoring Board (DSMB).

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

• Provides reports and statistics in the dissemination of safety information to the Clinical Trial Affairs (CTA) team members and clinical trial core team members, as appropriate, including CEC meeting minutes, DSMB meeting minutes and completion and summary reports as needed.

• Participates in or is responsible for reconciliation of drug safety databases and clinical study databases for adverse event reporting and tally.

• Receive record, review and prepare narratives of adverse events as reported by principal investigators participating in clinical studies sponsored or managed by Icahn School of Medicine at Mt Sinai

• Narratives will be written thoroughly and concisely by the narrative writer upon review of Admission notes with History & Physical Exam, Diagnostic Investigation Reports (echocardiography pre- and post-procedure, ECGs, etc.), Laboratory results (hematology, cardiac enzymes, creatinine, BNP, INR etc.), medications, consult summaries (cardiology), Diagnostic investigation reports (CT, MRI, angiograms, EGDE, etc).

• Synthesize 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.

• Participates with the 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 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

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

Compensation

The Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $58661 - $81675 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

Employer Description

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!