Clinical Study Assistant

This is a hybrid a role on-site 3 non-consecutive days inclusive of a Monday or Friday, and 2 days from home each week. A fully remote role is not possible for this role.

The Clinical Study Assistant (CSA) in Clinical Trial Managementis 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. 

In a typical day you 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
• Participate in Clinical Study team meetings for one or more clinical studies
• Assist in the writing, collection, distribution and filing of meeting agenda and meeting minutes
• Suppor the scheduling and coordination of team meetings and minutes
• Distribute materials to study sites, as directed
• Assist with requesting, collecting, and reviewing site regulatory documents 
• Track 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
• Support and participate in tracking organization and maintenance of study reporting tools such as monitoring visit schedules
• Collate and assemble 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
• Maintain team document repositories and/or shared drive sites as needed
• Assist or drive the submission process for internal review committees (e.g., Clinical Review Committee) and may attend review meetings on behalf of the study team
• Request and track 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.
• Ensure scheduled reports are received, reviewed and actioned (i.e. FDA Form 1572 reportable changes, financial disclosure form status)
• Track and monitor 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

To be considered you must have:

• 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
• General understanding of the clinical research process and regulations/guidelines
• Regularly contributes useful ideas for own work area/team, within defined parameters
• 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

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 a