• Trial documentation: Support the preparation of study files and of any other document required pre-trial.

Study Start Up Activities / Site start-up

• Support the Trial Manager (TM) or the Site Manager (SM) in EU-CTR Submission Preparation.

• Help the SM in obtaining site related trial documents.

• Support the TM/SM in collecting and processing as appropriate the IFDF and related documents throughout the trial.

• Help in the distribution, collection, reviewing, and tracking of regulatory documents, agreements, and training documentation.

Study Execution Activities

• Support TM/SM in ensuring that during the trial all relevant trial related documentation is provided to investigators and EC (if applicable) within the timelines.

• Support the TM/SM in maintaining the study files.

Study Close Out Activities

• Site closure: Provide administrative and logistic support to the TM/SM in activities related to study/site closure, as appropriate, and follow up of all items identified.

General Activities

• Base all actions on Credo. Protect the rights of others, protect privacy and company assets.
• Work in line with the HCC, company policies and procedures, including SOPs, having the ethical aspect in mind. Comply with ICH-GCP and all applicable local laws and regulations.
• Maintain communication with relevant parties within and outside the company.
• Actively follow trainings to ensure adequate qualification.
• Regularly update information in applicable systems and templates
• Contribute to maintain quality standards and timelines that are consistent with business needs

• Report every J&J product related complaint you receive to the company, according policies

Required Skills:

The anticipated pay range and benefits for this position is: