Start-Up Associate Milano

Start-Up Associate
Milano
Lombardia, Milano

Primary contact and liaison with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB submissions are made within the timelines agreed with project management and Start-up team.

Essential Job Duties:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.

? Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance;

? Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines;

? Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner;

? With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements;

? May support / assist the contract negotiation process under supervision of an experienced colleague or line manager;

? Escalate study issues appropriately and in a timely fashion;

? Update study documents when there are changes in study personnel/study amendments;

? Contribute to the preparation of submissions to IRB/IEC with appropriate supervision;

? Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Labcorp ready for an audit at any time;

? Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision

? Perform other duties as assigned by management.

Minimum Experience Required:

? Minimum 0 - 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job;

? Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.

Demonstrated basic understanding of the clinical trial process.

**Education**:

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e. g. , nursing certification, medical or laboratory technology)

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