Clinical Study Specialist at Regeneron Pharmaceuticals

$90,700 - $90,700/Yr

Unclassified - Basking Ridge, NJ

Full-time - Entry Level

Onsite - Basking Ridge, NJ

About the position

The Clinical Study Specialist (CSS) provides essential technical and administrative support to the clinical study teams responsible for executing clinical trials. This role is pivotal in ensuring that studies are conducted efficiently and in compliance with regulatory standards. The CSS may be assigned to support the execution of one or more studies across a program, receiving assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will be involved in both internally sourced studies and those outsourced to Clinical Research Organizations (CROs). This position is hybrid, requiring the individual to work onsite three days a week, as 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 agendas, presentation materials, and minutes for clinical study team meetings. The CSS is responsible for collating data for assessments such as feasibility and site selection, reviewing site usability databases, and contributing to the review of study documents, including informed consent forms and case report forms, in accordance with company standard operating procedures. Additionally, the CSS compiles study manuals, maintains versioning of study reference materials, and collates materials for training and investigator meetings. The CSS also tracks site activation, enrollment, and monitoring visits against projected plans, escalating any issues or delays with site activation or deviations from the monitoring plan. They monitor and update investigator/site status for the trial, support clinical trial registry postings, and perform scheduled reconciliations of the study Trial Master File (TMF) under the guidance of the clinical study lead. Ensuring that scheduled reports are received, managing team SharePoint and/or shared drive sites, and maintaining communication with sites are also key responsibilities. The CSS may manage or contribute to the oversight of Third-Party Vendors (TPV) and track close-out activities, including study close-out documents and CRA close-out visits. Participation in Standard Operating Procedures (SOPs) revisions and departmental initiatives is expected, along with proactively recommending process improvement initiatives for the department.

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 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, 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 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 (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) 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 in lieu of a Bachelor's degree, with a focus in clinical operations or trial management.
• 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