Regeneron Pharmaceuticals Temp Clinical Trial Operations Associate II in Tarrytown, New York
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Under general supervision, the CTOA II supports, coordinates, and implements clinical research projects. Assists and works with the study team in the initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Regeneron SOPs/WPDs. The CTOA II executes assignments with general instruction; more instruction may be required for new projects. Travel to study sites may be required to assist with monitoring clinical studies. The CRA II may have site responsibility.
• Supports the CTM or project manager with study start up and execution
• Interacts with CRO, central laboratory, IVRS systems as needed.
• Follows established clinical study standards and procedures to plan and conduct clinical research studies
• Assists with and/or may play a lead role in the development of procedures and tools for data collection
• Acts as a second point of contact between team members, vendors and study sites to assist with study conduct
• Requests, collects and submits site documents
• Reviews study start up documents and disseminates to the appropriate functional groups (i.e. legal, regulatory)
• Tracks study start up status
• Establishes and maintains the study TMF with minimal guidance
• Maintains CTMS and acts as a reference point for the CTM department on study status and CTMS management
• Compiles and maintains regular status reports of study progress, and ensures information is provided to management
• Collates and distributes study related materials
• Collates and assembles study binders (regulatory, pharmacy, laboratory), study reference manuals and study data collection tools
• Manages and maintains team SharePoint and/or shared drive sites as needed
• Maintains study specific timelines, and provides information as needed to the study team
• Submits required material to internal review committees (RCRC) and may attend review meetings on behalf of the study team
• Requests CDAs and consulting agreements
• Participates in tracking and reporting of study data for management reports
• Assists with reviewing monitoring visit reports
• Accompanies the CTM or CRA on site monitoring visits
• May have site management responsibilities
• Assists with vendor management
• Applies knowledge of company policies and standard practices to resolve problems
• Assists with and/or may play a lead role in the development of study documents including informed consent forms, data collection tools and procedure manuals
• Maintains open communication channels with study sites and members of the study team to ensure proper study progress
• Analyzes issues and uses judgment to make decisions
• Escalates non-standard problems or issues as may be required
• Participates in process improvement initiatives for the department
• Problem solving abilities, troubleshooting and resourcefulness
• Analytical problem solving experience
• Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA regulations
• Effective communication and interpersonal skills; ability to build relationships internally and externally
• Familiarity with medical terms
• Understands current and possible future business trends and information
• Demonstrates writing skills to deliver messages effectively so messages are clearly understood
• Proficiency in Microsoft Office applications
Bachelor’s degree and a minimum of 3+ years’ industry related work experience or an advanced degree in a related field with a minimum of one (1) to two (2) years of relevant work/therapeutic expertise.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.