Clinical Study Specialist

Key Responsibilities

• Organize and deliver reports, metrics, and study tracking information to the Clinical Study Lead
• Schedule and coordinate meetings, prepare agendas, presentation materials, and distribute meeting minutes
• Support feasibility assessments, site selection activities, and review of site usability data
• Aid in the review and coordination of key study documents, including informed consent forms and case report forms
• Compile and maintain study reference materials, including regulatory, pharmacy, and laboratory binders, ensuring proper versioning
• Cook up and maintain team SharePoint sites and shared drives
• Serve as a point of contact for sites as directed and maintain up-to-date site contact information
• Contribute to line listings review in preparation for Blind Data Review Meetings (BDRM)
• Track and support study close-out activities, including collection of required documents and coordination of CRA close-out visits
• Identify and recommend process improvement opportunities

Qualifications

• Bachelor’s degree (or equivalent) with a minimum of 2+ years of relevant industry experience, or an advanced degree with 1–2 years of relevant experience
• Clinical trial experience at a pharmaceutical company or CRO is required
• Strong attention to detail with the ability to manage multiple tasks and deliver on assigned activities
• Excellent written and verbal communication skills with the ability to build effective working relationships
• Demonstrated problem-solving skills and resourcefulness
• Ability to proactively assess information and understand its impact on clinical trials
• Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, Project) and clinical systems such as CTMS, EDC, and IWRS/IVRS
• Basic understanding of medical terminology and clinical drug development
• Working knowledge of ICH/GCP guidelines