What are the responsibilities and job description for the Clinical Study Assistant position at Regeneron?
The Clinical Study Assistant (CSA) in Clinical Trial Management is responsible for supporting the clinical study team(s) members in the initiation, maintenance, and closeout of clinical trials according to Good Clinical Practice (GCP), International Conference for Harmonization (ICH), Code of Federal Regulations (CFR) and Regeneron Standard Operating Procedures (SOP). The CSA assists the Clinical Study Lead and/or other clinical study team with all aspects of study execution.
Essential Functions required for the job.
This role will be a key study team member responsible for multiple clinical trials (all phases) and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines
Participates in Clinical Study team meetings for one or more clinical studies
Assists in the writing, collection, distribution and filing of meeting agenda and meeting minutes
Supports the scheduling and coordination of team meetings and minutes
Distributes materials to study sites, as directed
Assists with requesting, collecting, and reviewing site regulatory documents
Tracks site study start up status and activities using established study tools
Review, maintain, and reconcile (QC) essential study documents and electronic Trial Master File (eTMF) according to TMF plan
Supports and participates in tracking organization and maintenance of study reporting tools such as monitoring visit schedules
Collates and assembles study documents under guidance of the study specialist or study manager for: study binders (regulatory, pharmacy, laboratory), study reference manuals, CRA training and Investigator Meeting materials, and study data collection tools
Maintains team document repositories and/or shared drive sites as needed
Assists or drives the submission process for internal review committees (e.g., Clinical Review Committee) and may attend review meetings on behalf of the study team
Requests and tracks Clinical Disclosure Agreements (CDA) and consulting agreements
May assist with study related tasks including reviewing monitoring visit reports and providing feedback to the CSL, supporting the quality notification process, and data review process.
Uses judgment to escalate issues to the appropriate team members for consideration and resolution
Learns and implements company policies, procedures, quality, regulations, and compliance standards
Works with other internal departments to provide and receive required information required for achievement of assignments, goals, and objectives
Monitors and maintains clinical trial results posting requirements
Ensure accurate and up to date information in clinical trial management system (CTMS)
Complete and oversee activities related to Apostille/notary of essential trial documents
Responsible for generation of study-level financial requisition requests in the appropriate system
Ensures scheduled reports are received, reviewed and actioned (i.e. FDA Form 1572 reportable
changes, financial disclosure form status)
Tracks and monitors study close out activities – including study close-out documents (FDA Form 1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and Clinical Research Associate (CRA) close-out visits
May require 25% travel
JOB REQUIREMENTS
Recognizes and resolves basic, routine, or common problems s/Troubleshooting abilities and resourcefulness
General understanding of the clinical research process and regulations/guidelines
Regularly contributes useful ideas for own work area/team, within defined parameters
Seeks out new assignments to learn and develop
Effective communication and interpersonal skills; ability to build relationships internally and externally, as required
Familiarity with medical terminology
Proficiency with Microsoft Office applications, Excel and PowerPoint
Good time management, ability to prioritize
Effective written and verbal communication skills
Attention to detail and accuracy of work
Comfortable multi-tasking in a fast-paced environment and able to adjust workload based upon changing priorities
Escalates non-routine matters and complex problems, as needed
Minimum Years of Experience:
0-1 year experience (Entry Level), Bachelor’s degree preferred, Associates Degree may be accepted. Preference to candidates with a life science or nursing degree
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (hourly) $33.94 - $55.38
Essential Functions required for the job.
This role will be a key study team member responsible for multiple clinical trials (all phases) and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines
Participates in Clinical Study team meetings for one or more clinical studies
Assists in the writing, collection, distribution and filing of meeting agenda and meeting minutes
Supports the scheduling and coordination of team meetings and minutes
Distributes materials to study sites, as directed
Assists with requesting, collecting, and reviewing site regulatory documents
Tracks site study start up status and activities using established study tools
Review, maintain, and reconcile (QC) essential study documents and electronic Trial Master File (eTMF) according to TMF plan
Supports and participates in tracking organization and maintenance of study reporting tools such as monitoring visit schedules
Collates and assembles study documents under guidance of the study specialist or study manager for: study binders (regulatory, pharmacy, laboratory), study reference manuals, CRA training and Investigator Meeting materials, and study data collection tools
Maintains team document repositories and/or shared drive sites as needed
Assists or drives the submission process for internal review committees (e.g., Clinical Review Committee) and may attend review meetings on behalf of the study team
Requests and tracks Clinical Disclosure Agreements (CDA) and consulting agreements
May assist with study related tasks including reviewing monitoring visit reports and providing feedback to the CSL, supporting the quality notification process, and data review process.
Uses judgment to escalate issues to the appropriate team members for consideration and resolution
Learns and implements company policies, procedures, quality, regulations, and compliance standards
Works with other internal departments to provide and receive required information required for achievement of assignments, goals, and objectives
Monitors and maintains clinical trial results posting requirements
Ensure accurate and up to date information in clinical trial management system (CTMS)
Complete and oversee activities related to Apostille/notary of essential trial documents
Responsible for generation of study-level financial requisition requests in the appropriate system
Ensures scheduled reports are received, reviewed and actioned (i.e. FDA Form 1572 reportable
changes, financial disclosure form status)
Tracks and monitors study close out activities – including study close-out documents (FDA Form 1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and Clinical Research Associate (CRA) close-out visits
May require 25% travel
JOB REQUIREMENTS
Recognizes and resolves basic, routine, or common problems s/Troubleshooting abilities and resourcefulness
General understanding of the clinical research process and regulations/guidelines
Regularly contributes useful ideas for own work area/team, within defined parameters
Seeks out new assignments to learn and develop
Effective communication and interpersonal skills; ability to build relationships internally and externally, as required
Familiarity with medical terminology
Proficiency with Microsoft Office applications, Excel and PowerPoint
Good time management, ability to prioritize
Effective written and verbal communication skills
Attention to detail and accuracy of work
Comfortable multi-tasking in a fast-paced environment and able to adjust workload based upon changing priorities
Escalates non-routine matters and complex problems, as needed
Minimum Years of Experience:
0-1 year experience (Entry Level), Bachelor’s degree preferred, Associates Degree may be accepted. Preference to candidates with a life science or nursing degree
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (hourly) $33.94 - $55.38
Salary : $34 - $55
