Clinical Trial Assistant- Intern

Description

• Site Identification: Support the local study team in performing country and/or site feasibility.
• Trial documentation: Support the preparation of study files and of any other document required pretrial. Study Start Up Activities / Site start-up
• Help LTM/SM/CTA in ensuring that the current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
• Support the LTM/SM/CTA in collecting/preparing documents required for study start-up and ECs and/or Health Authorities Submissions.
• Help the SM in obtaining site related trial documents.
• Support the LTM/SM/CTA in collecting and processing as appropriate the IFDF and related documents throughout the trial.
• May assist the LTM/SM/CTA in conducting local investigator meeting or with 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.
• Support LTM/SM/CTA in drug distribution process, where applicable.
• Support LTM/SM/CTA in ensuring that during the trial all relevant trial related documentation is provided to investigators and central / local IEC (if applicable) within the timelines.
• Support the LTM/SM/CTA in maintaining the study files.
• Provide administrative and logistic support to LTM/SM/CTA in tracking of progress of the trial, management of study data, organizing meetings, mailing and correspondence, materials and other relevant tasks as appropriate, where applicable.
• Site closure: Provide administrative and logistic support to the LTM/SM/CTA in activities related to study/site closure, as appropriate, and follow up of all items identified, including support in collecting, processing and archiving of study related documents as appropriate.
• Comply with ICH-GCP and all applicable local laws and regulations.
• Maintain communication with relevant parties within and outside the company.
• Actively follow trainings and complies with relevant training requirements to ensure adequate qualification.
  
  

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
• Skills set corresponding with 0-2 years relevant clinical trial experience is preferred; however, other relevant
• Proficient in English language.
• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
• Strong interpersonal and negotiating skills preferred.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
• Ability to perform activities in a timely and accurate manner.