Temp-Clinical Study Specialist

Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: May 16, 2022

Job Description:

The Temp - Clinical Study Specialist (CSS), provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The individual may be assigned to support the execution of one or more studies across a program. The Temp - CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).A typical day might include the following:

• Organizes and delivers analyzable reports and metrics to the Clinical Study Lead (CSL)
• Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for study team 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 (SOPs)
• Compiles study manuals including 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 escalate 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 CSL 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 advised and maintains site contact information
• Tracks and monitors close out activities - study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
• Participates in SOPs revisions or departmental initiatives
• Proactively recommends process improvement initiatives for the departmentThis role might be for you if:You have strong attention to detail to track information and deliver on assigned study activitiesYou have good communication and interpersonal skills, with an ability to build relationships internally and externallyYou can be resourceful and demonstrate problem solving skillsYou demonstrate the ability to proactively assess information and investigate the impact on clinical trialsYou are interested in acquiring further knowledge of clinical trial management activitiesYou are proactive and self-disciplined, you can meet deadlines, and effectively use your time and prioritizeTo be considered for this opportunity you must possess:
  • Bachelor's degree with 2+ years of relevant experience. In lieu of a Bachelor's Degree 5+ years of relevant experience
    • 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/GCPDoes this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Keywords: Regeneron Pharmaceuticals, Inc., Newark , Temp-Clinical Study Specialist, Healthcare , Basking Ridge, New Jersey