My oncology pharmaceutical client with late phase, ongoing studies is seeking a home based/remote Senior Clinical Trial Assistant (CTA) responsible for supporting the operational aspects of multiple studies across all phases of a trial (planning, start-up, execution, data analysis, reporting and closure).
Home-office based in the New York City Metro Area (NY, NJ, or CT), responsibilities include generation of progress tracking reports, analysis / follow-up, trial specific system set-up and access management, system data entry, meeting arrangement / minute capture, document management, and investigator meeting set-up and coordination.
Working along side a peer CTA already on the team, the purpose of this senior CTA position is, as a key member of the study team, to provide the needed support to achieve operational deliverables across the existing ~7 studies.
Requirements to be qualified for this position include:
Home-based in the New York City Metro Area (NY, NJ, or CT); 100% remote position
Bachelor’s degree in science or related field
Clinical research experience in industry (sponsor or CRO) is required. (Preferred: CCRP training / certification)
General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines and applicable regulatory regulations
Advanced knowledge of clinical study processes
Basic understanding of the DIA and/or OASIS Trial Master File reference model and the ability to navigate an eTMF
Highly proficient in MS Office applications
Well organized and detail oriented with strong written and verbal communication skills.
Effective time management and organizational skills
Significant attention to detail
Highly effective interpersonal and customer service skills
Key Responsibilities/ Essential Functions
Participate in team meetings and draft meeting agendas, minutes, and tracking of action items.
Support study teams with administrative tasks and investigational site regulatory document review.
Assist in the creation of study materials, including study documents, site and patient facing materials, presentations, plans and reports.
Prepare and coordinate materials for investigator meetings and monitoring visits such as presentations, templates, outstanding essential document listings.
Distribute trial related materials to sites and / or study team members.
Develop and maintain tracking tools for assigned trials to monitor study progress and update study management reports as necessary (e.g., CRO metric compliance, performance indicators, invoices and study payments, patient enrollment).
Central contact for designated project communications, correspondence, and associated documentation.
Manage clinical study documents that includes reviewing for completion, accuracy, and expiration.
Coordinate the collection and review of essential documents to authorize initial study drug shipment(s) and site activation(s).
Perform ongoing reviews of TMF inventory for missing and expiring documents; and conduct periodic quality assessments of vendor managed TMF activities for outsourced studies.
Support maintenance of the Trial Master File (TMF) and assist in quality control as appropriate.
Assist with the collection and review of essential documents for completeness and compliance with SOPs, the protocol and appropriate governmental regulations.
Participate in edit check testing and user acceptance testing of study systems.
Generate reports or consolidated trackers to assist the study team with patient profile and clinical data reviews.
Participate in functional and cross-functional initiatives.
Perform other activities as assigned.