Clinical Trial Specialist

The Temporary Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The Clinical Study Specialist may be assigned to support the execution of one or more studies across a program. Receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. You will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs). This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

About the Role

When & where: Location: Armonk, NY Hybrid; 4 days per week onsite Contract Duration: 6 Months Discover your role:

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 (e.g., regulatory, pharmacy, and laboratory binders)
• Tracks site activation, enrolment and monitoring visits to projected plans
• 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)
• Contributes to line listings review for Blind Data Review Meeting (BDRM)
• Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits

Qualifications

• Minimum of a Bachelor's degree of
• 2+ years’ industry related work experience in a clinical research setting (CRC, CTA, etc.)

Required Skills

• 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