Clinical Study Specialist

Role Summary

The Clinical Study Specialist (CSS) provides technical and administrative support to clinical study teams responsible for trial execution. The CSS may be assigned to support one or more studies within a program and receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The role supports internally sponsored studies and studies outsourced to CROs. This is an onsite position; fully remote work is not possible.

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 and case report forms; facilitates study document reviews per SOPs
• Compiles study manuals (e.g., study reference binders and manuals) and maintains versioning of study reference materials (regulatory, pharmacy, and laboratory binders)
• Collates materials for training and investigator meetings
• Tracks site activation, enrollment and monitoring visits to projected plans and escalates issues or delays with site activation or deviations from the monitoring plan
• Monitors and updates investigator/site status for the trial and supports clinical trial registry postings
• Performs scheduled reconciliations of the Trial Master File (TMF) with guidance from the clinical study lead
• Ensures scheduled reports are received (e.g., 1572 changes, financial disclosures)
• Manages and maintains team SharePoint or shared drive sites as needed
• Communicates with sites 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, including study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
• Participates in SOP revisions or departmental initiatives and proactively recommends process improvements

Qualifications

• Required: Bachelor’s degree with 2+ years of relevant experience. In lieu of a Bachelor’s Degree, an Associate’s Degree with 5+ years of relevant experience.

Skills

• Attention to detail and the ability to track information and deliver on assigned study activities
• Good communication and interpersonal skills; ability to build relationships internally and externally
• Resourceful with strong problem-solving abilities; proactive in assessing information and its impact on clinical trials
• Demonstrated ability to acquire working knowledge in trial management systems and MS applications (including Project, PowerPoint, Word, Excel) and systems such as IVRS/IWRS, EDC, TMF
• Proactive and self-disciplined, with the ability to meet deadlines, manage time effectively, and prioritize
• Basic familiarity with medical terms and clinical drug development
• Awareness of ICH/GCP

Additional Requirements

• May require 25% travel