Start-up Associate

hace 2 meses

Santiago de Chile Fortrea A tiempo completo

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Job 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 proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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