Clinical Trial Support Intern
Location: Sofia
Duration: 12 months
Sector: Pharma
Type: part-time (20hours/week) / full time
Working at Johnson & Johnson can change everything. Including YOU.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in the UK are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
Study Planning Activities
Site Identification: Support the local study team in performing country and site feasibility
Trial documentation: Support the preparation of study files and of any other document required pre-trial.
Study Start Up Activities / Site start-up
Help manager in ensuring that the current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site.
Support the manger in ECs and Health Authorities Submissions.
Help the SM in obtaining site related trial documents.
Support the manager in collecting and processing as appropriate the IFDF and related documents throughout the trial.
Assist the manager in conducting local investigator meeting or in making arrangements for the investigators participating in an international meeting as applicable
Help in the distribution, collection, reviewing, and tracking of regulatory documents, start-up documentation from sites, agreements and training documentation.
Study Execution Activities
Support manager in drug distribution process, where applicable.
Support manager in ensuring that during the trial all relevant trial related documentation is provided to investigators and central IEC (if applicable) within the timelines.
Support the manager in maintaining the study files.
Provide administrative and logistic support to MANAGER in tracking of progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence and other relevant tasks as appropriate, where applicable
Support manager and CTA in up-loading documents into vTMF
Support manager in set-up new study site team members in CTMS
Support SM in study medication accountability at site under SM supervision. SM is accountable for the whole task, and all ensure that all confidentiality and data privacy rules are followed
Support CTA/SM in simple equipment calibration management (e.g. thermometer)
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