Clinical Trial Assistant- Intern

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.
Qualifications
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.