Regulatory and Site Readiness Specialist Ii

4 settimane fa

Roma, Italia Labcorp A tempo pieno

We are seeking a Study Start Up Specialist to be responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient recruitment time.

**Additional responsibilities include**:

- Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness and adherence to ICH/GCP
- Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study
- Prepare and submit regulatory and IRB/IEC documentation as required during the course of the study
- Preparation, tracking, and distribution of site start up documentation including Investigator Site File
- Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met
- Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality
- Monitor internal start up KPIs across studies and identify and communicate trends
- Support start up process improvement implementation
- In collaboration with CRA, maintain and ensure accuracy of site information
- Assist with audits/inspections of relevant start up activities and/or eTMF
- Attend and actively participate in team meetings by providing site greenlight projections and timelines
- Provide input on site activation strategy
- Ensure awareness of related local regulations and support maintenance of country intelligence

**Requirements**:

- The incumbent should have a Bachelor’s degree (or equivalent) and minimum of 2 years of experience in clinical development including start up/ regulatory process experience
- Understanding of ICH-GCP essential documentation and familiarity with country specific clinical trial regulations
- Demonstrated ability to quality review documents and identify discrepancies/inconsistencies preferred
- Ability to embrace Veeva Clinical Vault system and associated functionality
- Strong written and verbal English communication skills
- Flexibility to adapt to changing business needs and priorities
- Demonstrated organization skills and attention to detail
- Strong service orientation
- Ability to work independently and manage multiple tasks and priorities

**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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