Inhouse Clinical Research Associate

1 giorno fa

Italia Novotech A tempo pieno
Description

 About the Role

The Inhouse Clinical Research Associate (IHCRA) provides in-house administrative support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.

Responsibilities

  • Support the Clinical Research Associates (CRAs) with in house activities on assigned projects. 
  • Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs.
  • Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs. 
  • In collaboration with Regulatory Start Up team, co-ordinate the distribution of ethics and regulatory submission documents including any amendments. Additionally, co-ordinate submission of Import or Export applications including customs requirements as requested by the clinical team. 
  • Assist with maintenance of the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Update and maintain site milestones including EC/HA submissions and approvals, subject tracking and PISCF's, ensuring accuracy and completeness of the data.
  • Creation of the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials (e.g. patient cards and diaries, lab supplies, drug supplies etc.) according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.

Experience and Qualifications

Relevant experience/qualifications in Life Sciences or related field or administration would be preferable. Experience working in the pharmaceutical, CRO or healthcare industry is advantageous

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. 

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. 

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. 

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.

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