Temp Clinical Trial Operations Associate
Position Summary
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.
Summary:
Under general supervision, the CTOA I 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 I 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.
Responsibilities:
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
Requirements:
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 with a minimum of 2
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.
Requisition Number: 10037BR
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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.
Summary:
Under general supervision, the CTOA I 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 I 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.
Responsibilities:
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
Requirements:
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 with a minimum of 2
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.
Requisition Number: 10037BR
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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