Sr. Clinical Trial Specialist - Contract - Boston - Remote
Ready to play a pivotal role in bringing innovative clinical studies to life while ensuring flawless trial execution?
Proclinical is seeking a Sr. Clinical Trial Specialist for a contract-to-permanent opportunity.
Primary Responsibilities:
The successful candidate will support the planning and execution of clinical studies across one or more trials. Working closely with the Clinical Trial Manager (CTM), you will ensure that site start-up through close-out activities are conducted in compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory guidelines.
Skills & 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.
The Sr. Clinical Trial Specialist's responsibilities will be:
- Provide operational support to the 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, and presentation materials, as well as 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.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsen@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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