Clinical Study Specialist at Regeneron Pharmaceuticals

$90,700 - $148,100/Yr

Regeneron Pharmaceuticals - Basking Ridge, NJ

Full-time - Entry Level

Onsite - Basking Ridge, NJ

Professional, Scientific, and Technical Services

About the position

The Clinical Study Specialist (CSS) provides essential technical and administrative support to clinical study teams involved in the execution of clinical trials. This hybrid role requires the CSS to work onsite three days a week and involves supporting both internally sourced studies and those outsourced to Clinical Research Organizations (CROs). The CSS plays a critical role in organizing reports, coordinating meetings, managing study documentation, and ensuring compliance with study protocols.

Responsibilities

• Organizes and delivers analyzable reports and metrics to the clinical study lead
• Schedules and coordinates meetings, prepares agendas, presentation materials, and minutes for clinical study team meetings
• Collates data for assessments such as feasibility and site selection and reviews site usability database
• Contributes to the review of study documents such as informed consent forms and case report forms
• Compiles study manuals and maintains versioning of study reference materials
• Tracks site activation, enrollment, and monitoring visits to projected plans
• Monitors and updates investigator/site status for the trial
• Performs scheduled reconciliations of study Trial Master File (TMF)
• Ensures scheduled reports are received
• Manages and maintains team SharePoint and/or shared drive sites
• Communicates with sites as directed and maintains site contact information
• Contributes to line listings review for Blind Data Review Meeting (BDRM)
• Tracks and monitors close-out activities and study close-out documents
• Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
• Proactively recommends process improvement initiatives for the department

Requirements

• Bachelor's degree with 2+ years of relevant pharmaceutical industry experience
• In lieu of a Bachelor's Degree, 5+ years of relevant pharmaceutical industry experience with a focus in clinical operations or trial management

Nice-to-haves

• Strong attention to detail
• Strong communication and interpersonal skills
• Resourcefulness and problem-solving skills
• Ability to proactively assess information and investigate impact on clinical trials

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off