Job Description

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office.

SUMMARY
The incumbent in this position will have primary responsibility for the development, implementation, ongoing monitoring, and report generation for the safety aspects of clinical studies conducted or supported by CRF. They will lead a professional medical team of Clinical Safety Reviewers (CSRs) / Clinical Safety Associates (CSAs) and work closely with the Manager, Device / Drug Safety Information, other Clinical Trial Managers and Project Managers to provide a true representation of CRF clinical trial safety. The Clinical Safety Monitor (CSM) is viewed as the resident expert on all safety related study activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Serves as the main liaison between the different bodies involved in the safety process, i.e. between the Data Safety Monitoring Board (DSMB), Clinical Events Committee (CEC), Contract Research Organizations (CROs), Investigators, Clinical Trial Study teams and vendors.
• Responsible for all activities related to establishing and managing all safety-related policies and procedures, departmental SOPs, CEC Charters, DSMB objectives and other documents requiring safety direction.
• Participates in the preparation and completion of critical clinical trial study documents with regards to safety and performs final editing/proofing prior to publishing (e.g. protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; statement of work for laboratory and other vendors, CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.).
• Supports ongoing clinical studies through review of medical safety databases; creating narrative reports for notable clinical events; assisting sites with subject evaluation and protocol adherence; and preparing safety reports to support regulatory notifications and filings.
• In concert with Clinical Trial Managers, establishes and chairs Data Quality Review Meetings (DQRM) for each clinical study; works with Biometrics and Data Management & Programming (BDM&P) to create appropriate clinical study listings and reports for safety data cleaning and reconciliation with clinical trial database; conducts proactive trigger detection activities to assure complete reporting of safety concerns according to the most current FDA, ICH and EMEA guidelines.
• Supports preparation of safety section of clinical study reports, clinical expert reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal (PMA) regulatory filings.
• Responsible for receiving initial and follow-up adverse events (AEs) reports via phone, fax, 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 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 DataSafety 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 as needed.
• 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 there follow-up.
• May train and mentor Data Coordinating & Analysis Center and other CRF 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.
• Provides Medical 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.
• Assists in developing and maintaining Device/Drug Safety Information (DSI) infrastructure such as the drafting and/or reviewing of SOPs, guidelines and work instructions.
• Assists 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 safety conduct, laws, regulations, and standards, and compliance with CRFs applicable SOPs.
• Additional duties as assigned.

QUALIFICATIONS

• M.D. or D.O. degree with 2-5 years of safety experience (Bachelor\xe2\x80\x99s degree in a life science, B.S.N., Registered Nurse, or equivalent with at least 4 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

COMPENSATION
The hiring range for this position is $90,000 - $98,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience.

CONTACT INFORMATION
To be considered for this opportunity, please submit your resume.
Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day www.crf.org

CRF is an equal opportunity employer.

Cardiovascular Research Foundation