**Job Function**:
Career Programs
**Job Sub**Function**:
Non-LDP Intern/Co-Op
**Job Category**:
Career Program
**All Job Posting Locations**:
ES024 Janssen Madrid Oficinas
**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.
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 logístical 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 logístical 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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