Clinical Study Associate, Clinical Operations

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Clinical Study Associate, Clinical Operations to join our Clinical Development team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

• Support multiple clinical trials while ensuring compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and regulations.
• Participate in study team meetings and coordinate agendas, minutes, and logistics.
• Request, collect, review, and track site regulatory documents and start-up activities.
• Maintain, reconcile, and quality check essential documents and the electronic Trial Master File (eTMF).
• Support study reporting tools, monitoring visit schedules, investigator materials, and study binders.
• Manage Clinical Disclosure Agreements, consulting agreements, and internal review committee submissions.
• Maintain accurate data in the Clinical Trial Management System (CTMS) and monitor trial disclosure requirements.
• Track study closeout activities, reports, financial requisitions, and Clinical Research Associate (CRA) closeout visits.

• Bachelor’s degree preferred;
  Associate degree may be accepted.
• 0-1 year of relevant experience.
• Knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulations.
• Experience reviewing and maintaining study documentation and electronic Trial Master Files (eTMF).
• Familiarity with Clinical Trial Management Systems (CTMS) and clinical reporting tools.
• Ability to coordinate study activities, regulatory documentation, and committee submissions.
• Strong organizational skills with attention to detail and document quality.
• Ability to collaborate across clinical study teams and internal departments.

We are committed to building a workplace with an inclusive culture.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

• Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit

For…