Clinical Study Specialist

$106,200 - $173,200/Yr

Regeneron Pharmaceuticals - Basking Ridge, NJ

Full-time - Mid Level

Onsite - Basking Ridge, NJ

Professional, Scientific, and Technical Services

About the position

The Clinical Study Specialist (CSS) at Regeneron Pharmaceuticals Inc. plays a crucial role in providing both technical and administrative support to the clinical study teams responsible for executing clinical trials. This position is essential for ensuring that studies are conducted efficiently and in compliance with regulatory standards. The CSS may be assigned to support one or more studies across a program, receiving assignments from the Clinical Study Lead or Clinical Study Associate Manager. The role involves supporting both internally sourced studies and those outsourced to Clinical Research Organizations (CROs). As a hybrid position, the CSS is required to work onsite three days a week, with the expectation that fully remote work is not an option. A typical day for a CSS may include organizing and delivering analyzable reports and metrics to the clinical study lead, scheduling and coordinating meetings, and preparing necessary materials such as agendas and minutes for clinical study team meetings. The CSS is also responsible for collating data for assessments like feasibility and site selection, contributing to the review of study documents, and compiling study manuals while maintaining version control of study reference materials. In addition to these tasks, the CSS tracks site activation, enrollment, and monitoring visits, escalating any issues or delays as necessary. They monitor and update the status of investigators and sites for the trial, support clinical trial registry postings, and perform scheduled reconciliations of the Trial Master File (TMF) under the guidance of the clinical study lead. The CSS also manages team SharePoint and shared drive sites, communicates with sites as directed, and may oversee Third-Party Vendors (TPV). The role requires proactive recommendations for process improvements and participation in revisions of Standard Operating Procedures (SOPs) or departmental initiatives. This position is ideal for individuals with a strong attention to detail, excellent communication and interpersonal skills, and the ability to form relationships both internally and externally. The CSS must be resourceful, demonstrate problem-solving skills, and proactively assess information to understand its impact on clinical trials.

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 the review of study documents such as informed consent forms and case report forms, facilitating study document reviews per company standard operating procedures.
• Compiles study manuals including study reference binders and maintains versioning of study reference materials.
• Tracks site activation, enrollment, and monitoring visits to projected plans, escalating any issues or delays with site activation or deviations from monitoring plan.
• Monitors and updates investigator/site status for the trial and supports clinical trial registry postings.
• Performs scheduled reconciliations of the study Trial Master File (TMF) with clinical study lead guidance.
• Ensures scheduled reports are received, including 1572 reportable changes and financial disclosure forms.
• 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, including 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, or 5+ years of relevant pharmaceutical industry experience with a focus in clinical operations or trial management if no degree is held.
• Strong attention to detail for tracking information and delivering on assigned study activities.
• Demonstrated strong communication and interpersonal skills; ability to form relationships internally and externally.
• Resourceful with demonstrated 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 for eligible employees at all levels