Supports the Clinical Affairs department by providing administrative support for the company’s clinical research program. S/he is involved in the conduct of the study and interfaces with the Study Manager and the Study Team. The Senior CTA supports the Study Team by creating, maintaining, and distributing study team materials, tools and documents.
Set up and maintains Sponsor Study Management Files, ensuring documentation is collected and filed in a timely fashion and the essential files required to conduct a clinical study are maintained in an “inspection ready” state.
Set up, assist, and performs quality checks of essential clinical documents uploaded to the electronic document control system.
Performs quality check of paper files for project and study-related documents to ensure their integrity and security.
Prepares clinical study supplies (e.g., case report form (CRF) binders, study pocket cards, protocols, Investigator’s Brochures, site training materials, etc.) and maintains tracking records.
Coordinates and maintains the company’s IRB submissions. Documents IRB renewal dates and notifies the clinical study team in a timely manner of upcoming milestone dates.
Assists with the maintenance of the electronic correspondence system for specified clinical trials.
Creates, revises and archives internal forms; assists in the formatting and preparation of study documents and reports in template format.
Maintains tracking records of product and study-related documents.
Assists in the preparation and filing of submissions to the regulatory authorities, and performs a quality check of all documents planned for regulatory submission.
Assists with the reconciliation of invoices from clinical trial sites, committee members and/or consultants.
Assists in the compilation of meeting materials for specified committees and/or consultants as needed.
Assists with document preparation for due diligence and/or inspections as required.
Performs a quality check of clinical trial data as required.
Tracks and organizes the paper or electronic Trial Master File (TMF) or performs ongoing quality checks of externally managed TMF.
Scans and saves essential documents for the electronic TMF (e-TMF) within the Clinical Operations server system under direction of the project manager.
Under the direction of the clinical project manager or clinical project specialist, interfaces with internal key stakeholders to coordinate shipment of investigational product to clinical sites.
Establish and maintain positive working relationships with study sites and project team members to ensure professional and timely communication and documentation for assigned project(s)
Internal Number: 1185
Invivoscribe is an industry pioneer in oncology diagnostics, dedicated to improving the standard of global healthcare for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used in over 160 countries. Our global network of laboratories offer next generation molecular and flow cytometry panels to support our drug development entity and accelerate clinical trials. Our harmonized clinical laboratories offer a menu focused on clinically significant biomarkers which support therapeutic decisions, minimal residual disease (MRD) monitoring, patient stratification, trial enrollment, and the development of companion diagnostics.
Invivoscribe has long established itself as a company built on integrity, innovation, and collaboration. As a team, we develop products and services that improve blood cancer diagnostics. For 25 years, we have stood at forefront of precision diagnostics, and we’re just getting started!