Job purpose
At Blue Earth Diagnostics, which is part of the Bracco Group, our mission is to transform the clinical management of patients with cancer by developing innovative molecular imaging technologies. Our team is made up of industry leaders in the field of radiopharmaceutical development and commercialization. Blue Earth Diagnostics is a dynamic and growing company with an approved product already on the market in the USA and in Europe, and a development pipeline of diagnostic radiopharmaceuticals.
The Clinical Trial Administrator (CTA) is responsible for supporting the Clinical Trial Manager (CTM) and wider Clinical Operations team for their assigned projects. This position is fundamental to the efficient execution of trials and supports overall compliance with Good Clinical Practice (GCP) and company Standard Operating Procedures (SOP’s).
Main Responsibilities, Activities, Duties and Tasks
* Set-up, prepare, handle, distribute, file and archive all essential and supportive clinical study documentation within the TMF (Trial Master File; paper or electronic), and be the point of contact for all queries on the assigned TMF(s).
* Responsible for periodic reviews of the study files for completeness.
* Support the assigned studies by maintaining adequate tracking of study specific documentation including but not limited to BED specific study timelines, Protocols, Investigators Brochures, Trial Master File Configuration Manuals, Combined Project and Sponsor Oversight plans, Informed Consent/Assent Documents.
* Support the assigned studies by maintaining adequate tracking of study statuses including but not limited to site set-up and participant recruitment.
* Assist the CTM in preparation for any internal audits or inspections and responding to any findings.
* Assist the Clinical Operations Team with creating purchase order numbers & general set-up and tracking of study contracts & budgets within BED financial software (Accenture SAP).
* Support the Clinical Operations Team with setting up face-to-face meetings, video conferences (VCs), Teleconferences (TCs) or other meeting formats, take minutes for Internal Project Team meetings and any other meetings as required.
* Perform other Trial, Project or Department related duties, as assigned. Other duties as determined by business needs.
Education
Bachelor’s degree or equivalent in life science or allied health fields such as nursing, pharmacy or health science, or long-standing experience in a similar role.
Professional Experience, Knowledge & Technical Skills
* Industry or clinical trial setting as a trial/study coordinator
* In depth knowledge of Clinical Trial conduct and eTMF setup and management
* Knowledge of current ICH/GCP guidelines
* Proven skills in minute taking
* Excellent organisational skills
* Ability to effectively prioritise workload
* Previous experience working in a matrix organisation
* Demonstrates collaboration skills and flexibility
* Ability to work under pressure
* Flexibility to work in a rapidly growing/changing organisation
* Familiarity with Accenture SAP (preferable)
Soft Skills – Company Values & Behaviours
* Excellent oral & written communication skills.
* Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
* Strong coaching, facilitation, and organizational skills.
* Team player.