At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
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ES024 Janssen Madrid OficinasJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
The objective of the Clinical Trial Assistant Student is to learn the main activities of a Clinical Trial Assistant (CTA) role that supports the Local Trial Manager (LTM) and/or Site Manager (SM) to ensure optimal management of all documents with logistical and administrative tasks related to trial startup, execution and closing of clinical trials. CTA Student will confirm that trial related activities are compliant with GCO SOPs, policies and local regulatory requirements.
Principal Activities CTA Student will be involved in as part of her training program :
Administrative and logistical support to LTM and/or SM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies and local regulatory requirements.
Support the local study team in performing site feasibility and/or country feasibility.
Maintain information in relevant systems.
Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
Support LTM and/or SM in collecting/preparing documents required for study start-up/submission to IEC/IRB and/or HA.
Support LTM and/or SM in collecting, processing and archiving study related documents as appropriate at designated study milestones.
May assist LTM in conducting local meetings or with making arrangements for the investigators participating in an international meeting (in person or remotely).
Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution.
Comply with all training requirements
Ensure inspection readiness at all times.
May contribute to process improvement.
Requirements:
Bachelor's Degree completed.
CTA course.
No more than 2 years of professional experience.
Fluent English.
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