Start Up Specialist

hace 2 semanas


Buenos Aires, Argentina Labcorp A tiempo completo

Maintain awareness of regulatory legislation, guidance and practice in the assigned countries
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable)
- Assist in the preparation of routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g. INDs/CTAs)
- Collect and compile documentation to complete submissions to IRB/IEC/Third body/Regulatory Authority and liaise with them as applicable regarding submission/approval
- Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards
- Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable]
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
- Participate in team and project meetings as applicable
- When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams
- Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites
- 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
- May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate
- Perform a review of final submission documents as applicable.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp 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.

For more information about how we collect and store your personal data, please see our Privacy Statement.



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