Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO,andmulti-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com .
As a SeniorClinical Trial Associate you are responsible for providing the administrative support to the clinical development / project teams and maintaining a range of clinical documentation. You will be focused on supporting external client teams as well as our internal Clinical Services team. Youwill work closely with project teams to ensure that Clinical Trial Administration is performed in line with ICH-GCP allowing successful delivery of trials whilst protecting subjects’ rights, safety and wellbeing and the production of reliable clinical trial data.
Position Accountabilities / Responsibilities :
* Support the clinical trial activities with regard to time, cost and quality and in accordance with SOPs, ICH-GCP guidelines and relevant regulations
* Set up and maintain the documentation folders associated with product development and the Trial Master File (TMF) in compliance with ICH-GCP
* Ensure the TMF index is kept up to date
* Coordinate the collection of essential documents during site set-up
* Assist in the development of processes and procedures in order to ensure that robust forecasting and scheduling of trials occurs
* Assist the project managers in the production of study reports and updates as required
* Set up trial specific meetings, taking minutes and tracking screening and enrolment across clinical sites
* Track and process investigator site payments
* Manage the clinical trial supplies for a study, including the tracking and shipment of materials e.g. lab kits
* Assists the project team with preparation and shipment of Clinical Trial documentation including : Investigator Site File, Pharmacy File, Investigator Brochure, Protocol and study manuals.
* Update and maintain trial tracking systems in accordance to the demands of the study e.g. investigational product tracking, payment tracking, monitoring visit tracking etc.
* Serve as an office-based point of contact for all sites during the trial
* Develop and maintain good working relationships with Investigators and study staff
* Assist with corporate administration activities according to need and availability
Position Qualifications and Requirements :
Education : Degree or equivalent qualification in life sciences or nursing
Experience :
* 2+ years’ experience in clinical trial processes and procedures including regulatory standards
Required Certifications : N / A
Required Skills :
* A good understanding of ICH-GCP and regulatory requirements
* Proven track record in working within clinical research in the pharmaceutical, CRO or NHS environment
* Experience in maintaining Trial Master Files / Investigator Site Files in compliance with ICH-GCP (ideally experience in using the DIA reference model).
* Ability to work collaboratively with others, influencing and managing conflict
* Willingness and ability to travel domestically (and occasionally internationally) as required
* Excellent verbal and written communication and interpersonal skills
* Strong organisational and time management skills with an ability to multi task and work independently
* Strong technical skills using PowerPoint, Excel and Word
Working Conditions : Sedentary work that primarily involves sitting / standing. Employee may be office or home based.
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