Clinical Study Specialist

$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) at Regeneron Pharmaceuticals 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 is responsible for organizing reports, coordinating meetings, managing study documentation, and ensuring compliance with regulatory standards.

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 and other study related meetings
• Collates data for assessments such as feasibility and site selection and reviews site usability database
• Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
• Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials
• Collates materials for training and investigator meetings
• Tracks site activation, enrollment and monitoring visits to projected plans, and escalates any issues or delays with site activation or deviations from monitoring plan
• Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
• Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
• Ensures scheduled reports are received (i.e., 1572 reportable changes, financial disclosure form)
• Manages and maintains team SharePoint and/or shared drive sites, as needed
• Communicates with sites as directed and maintains site contact information
• Contributes to line listings review for Blind Data Review Meeting (BDRM)
• May manage or contribute to oversight of Third-Party Vendors (TPV)
• Tracks and monitors close out activities - study close-out documents and CRA close-out visits
• 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