Temp Clinical Study Specialist (Oncology)

Pay Range: $52.88 - $60.09/hr

Hybrid Role (Armonk, NY or Basking Ridge, NJ)

12 Month Contract

Regeneron seeking a highly motivated Temp-Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).

This role requires a minimum of 3-days onsite in either Armonk, NY or Basking Ridge, NJ. This role is not eligible full remote, and relocation is not provided.

A typical day as a Clinical Study Specialist looks like:

• 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 (e.g., regulatory, pharmacy, and laboratory binders
• Collates materials for training and investigator meetings
• Tracks site activation, enrolment and monitoring visits to projected plans, and raise 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
• Communication 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
• May require 25% travel

This role may be for you if you have:

• Attention to details for the ability to track information and deliver on assigned study activities
• Good communication and interpersonal skills; ability to build relationships internally and externally
• Ability to be resourceful and to demonstrate problem solving skills
• Demonstrate the ability to proactively assess information and investigate impact on clinical trials
• Ability to acquire working knowledge in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Basic familiarity with medical terms and clinical drug development
• Awareness of ICH/GCP

In order to be considered qualified for this role, a minimum of a Bachelor’s degree with 2+ years of relevant clinical study experience required. Prior Oncology clinical study experience is highly preferred.

Reference# R33862

In order to be considered qualified for this role, a minimum of a Bachelor’s degree with 2+ years of relevant experience is required.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation