Sr. Clinical Trial Specialist

Proclinical is seeking a Sr. Clinical Trial Specialist for a contract-to-permanent opportunity based in Boston, with remote work options.

About the role

The successful candidate will support the planning and execution of clinical studies across one or more trials, ensuring site start-up through close-out activities are conducted in compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory guidelines.

Responsibilities

• Provide operational support to the Clinical Trial Manager (CTM) and study team for day-to-day management of assigned clinical trials.
• Coordinate and document internal and external meetings, including Kick-Off Meetings, Investigator Meetings, and vendor management meetings. Tasks include preparing agendas, minutes, presentation materials, and organizing logistics and travel arrangements if needed.
• Manage meeting logistics, agendas, and minutes for clinical study teams in line with established standards.
• Track purchase orders, invoices, site budgets, investigator payments, and Clinical Trial Agreements (CTAs).
• Monitor key site metrics and milestones, such as Site Initiation Visits, site activation, subject recruitment, enrollment, critical study dosing days, and scheduled monitoring visits.
• Maintain study-level tracking tools for assignments, training, recruitment materials, compliance tools, laboratory kits, samples, study supplies, and vendor portal access.
• Assist the CTM in overseeing study vendors, including invoice reviews.
• Contribute to the review of clinical documentation, such as Informed Consent Forms (ICFs), Study Reference Binders, Study Management Plans, Monitoring Plans, and study protocols.
• Manage and maintain the study team's SharePoint site.
• Support clinical site oversight, including data entry timeliness, monitoring trip report reviews, and tracking resolution of action items.
• Assist in maintaining the Trial Master File (TMF) to ensure it is up-to-date and all essential documents are appropriately filed.
• Support the CTM and study team in reviewing and cleaning study data in preparation for database lock.

Requirements

• Bachelor's degree (BA or BS) required.
• Experience in clinical trial operations within a biotechnology or pharmaceutical organization.
• Strong organizational and communication skills.
• Proficiency in managing multiple tasks and priorities effectively.
• Familiarity with GCP, SOPs, and regulatory guidelines.
• Experience with TMF management and clinical documentation review is a plus.