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Cardiovascular Research Foundation · 4 hours ago

Clinical Safety Reviewer

New York, NY

Full-time

Hybrid

Mid, Senior Level

$70K/yr - $78K/yr

2+ years exp

Cardiovascular Research Foundation is seeking a Clinical Safety Reviewer to be responsible for reviewing adverse event reports from clinical studies and post-marketing spontaneous reports. The role involves ensuring the completeness and clarity of reports, participating in regulatory reporting, and applying Good Clinical Practices in documentation.

Health Care

H1B Sponsor Likely

Responsibilities

Receives initial and follow-up adverse events (AEs) reports via email, case report forms and/or electronic data capture

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

Recognizes missing/incorrect data and initiates missing data queries/data clarification queries to clinical sites 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 Clinical Events Committee (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 Data 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 charter development and completion and summary reports

Participates in or is responsible for reconciliation of device / 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

May train and mentor other staff on safety processes

Reviews protocol safety sections, as well as, instructions for use of investigational devices before submission for FDA approval

Attends investigator and coordinator meetings representing the Device / Drug Safety Information (DSI) functional group

Provides advice on the reportability of adverse events and other clinical trial issues to regulatory agencies and health authorities

Provides Clinical Safety support in working with Food and Drug Administration, including 510(k) and Pre-Market Approval (PMA) submissions, responses to FDA questions, and preparation at FDA advisory panel

Participates in developing and maintaining Device / Drug Safety Information (DSI) infrastructure such as the drafting and/or reviewing of SOPs, guidelines and work instructions

Participates in the development and review of corrective action plans as requested on internal / external audits and implements plans as required

Demonstrates working knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with the Code of Federal Regulations (CFRs) and applicable Standard Operating Procedures (SOPs)

Qualification

Clinical Safety ExperienceM.D.D.O. DegreeMicrosoft Office ProficiencyClinical Triage SkillsCommunication SkillsOrganizational SkillsProject Management SkillsTime Management Skills

Required

M.D. or D.O. degree, (Bachelor's degree in a life science, B.S.N., Registered Nurse, or equivalent with at least 2 years safety experience may be considered)

Proficient with Microsoft Outlook, Word, and Excel; basic understanding of database programs is extremely helpful

Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike; ability to verbally communicate effectively with Biometrics & Data Management (BDM), Clinical Trial Affairs (CTA), Project Management (PM) and other team members

Ability to multi-task and interface with team members who are working under deadlines

Ability to set priorities and excellent organizational planning, project management and time management skills

Ability to analyze information and perform clinical triage relating to information synthesized from Case Report Forms and other sources

Benefits

Choice of health plans include medical, Dental, and vision coverage

Company-paid short-term and long-term disability and life insurance

Health and dependent care flexible spending accounts

Pre-tax travel expenses through TransitChek program

401(k) plan

Generous paid time off (PTO)

Ten paid holidays each year

Company

Cardiovascular Research Foundation

The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving.

Founded in 1989

New York, New York, USA

51-200 employees

http://www.crf.org

H1B Sponsorship

Cardiovascular Research Foundation has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (3)

2023 (4)

2022 (2)

2021 (1)

2020 (5)