עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!
במקום לחפש לבד בין מאות מודעות – תנו ל-Jobify לנתח את קורות החיים שלכם ולהציג לכם רק הזדמנויות שבאמת שוות את הזמן שלכם מתוך מאגר המשרות הגדול בישראל.
השימוש חינם, ללא עלות וללא הגבלה.
Description: PRINCIPAL TASKS AND DUTIES:
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.
Study Execution Activities
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.
Study Close Out Activities
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.
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 and complies with relevant training requirements to ensure adequate
qualification.
Regularly update information in applicable systems and templates (including contact information in
relevant systems to ensure appropriate safety updates distribution).
Use appropriate systems to ensure file completeness at designated study milestones.
Contribute to maintain quality standards and timelines that are consistent with business needs.
Ensure inspection readiness at all times.
Report every J&J product related complaint received to the company, according to policies.
May contribute to process improvement.
TV-eFRM-12840 – ISR - Intern Tasks Description, version 4.0
REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides.
Primary Reporting Structure: Reports to Intern Manager.
WORKING RELATIONSHIPS/INTERFACES: Describe the primary working relationships (internal & external) and primary
interfaces along with the frequency and purpose/nature.
Primary interfaces: CRM, LTM, CTA, and SM(s) for assigned clinical studies.
Other Internal interfaces: GCO Country Head, Clinical Trial Manager (CTM), Local Compliance Manager/Specialist,
Contracts Centralized Services (CCS).
Relationships with the following departments: Pharmacovigilance (SAEs), IT (technical support), Local Medication
Coordinator and Human Resources.
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.
במקום לחפש לבד בין מאות מודעות – תנו ל-Jobify לנתח את קורות החיים שלכם ולהציג לכם רק הזדמנויות שבאמת שוות את הזמן שלכם מתוך מאגר המשרות הגדול בישראל.
השימוש חינם, ללא עלות וללא הגבלה.