Clinical Study Assistant (CSA) Role
This is a hybrid role with 3 non-consecutive days on-site, including a Monday or Friday, and 2 days from home each week.
Job Summary
The Clinical Study Assistant (CSA) in Clinical Trial Management supports the clinical study team(s) 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).
Key Responsibilities
* Assist the Clinical Study Lead and/or other clinical study team members with all aspects of study execution.
* Participate in Clinical Study team meetings for one or more clinical studies.
* Support the scheduling and coordination of team meetings and minutes.
* Distribute materials to study sites, as directed.
* Track site study start up status and activities using established study tools.
* Review, maintain, and reconcile essential study documents and electronic Trial Master File (e TMF) according to TMF plan.
Requirements
* 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.
* Familiarity with medical terminology.
* Proficiency with Microsoft Office applications, Excel, and Power Point.
* Good time management and ability to prioritize.
* Effective written and verbal communication skills.
* Attention to detail and accuracy of work.
About Us
We have an inclusive and diverse culture that provides comprehensive benefits, which often include 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.