Madrid, Spain
Internship Explorer
Internship Explorer
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. 2. Study Start Up Activities / Site start-up Help LTM/SM in ensuring that the current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site. Support the LTM or the SM in ECs and Health Authorities Submissions. Help the SM in obtaining site related trial documents. Support the LTM/SM in collecting and processing as appropriate the IFDF and related documents throughout the trial. Assist the LTM/SM 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, agreements and training documentation. 3. Study Execution Activities Support LTM/SM in drug distribution process, where applicable. Support LTM/SM 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 LTM/SM in maintaining the study files. Provide administrative and logistic support to LTM/SM 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 4. Study Close Out Activities Site closure: Provide administrative and logistic support to the LTM/SM in activities related to study/site closure, as appropriate, and follow up of all items identified. 5. 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
