Start-up Associate

hace 2 semanas


Santiago, Chile Fortrea A tiempo completo

Description

¨ 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 Covance 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.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.


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