Full-Time Clinical Research Associate II

As a Clinical Research Associate at PSI, you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

You will:

1. Act as the main line of communication between the project team, sponsor, and the site
2. Build and maintain a good relationship with the site staff involved in the study conduct
3. Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
4. Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
5. Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
6. Perform source data verification and follow up on data queries at site level; review and manage study risks on a site level
7. Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
8. Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
9. Ensure quality (data integrity and compliance) at site level
10. Conduct site audit preparation visits and resolve site audit findings
11. Participate in study site audits and client onsite visits, as required
12. Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
13. Conduct project-specific training of site investigators
14. Support preparation of Investigator newsletters
15. Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
16. Support preparation of draft regulatory and ethics committee submission packages
17. Support collection of IP-RED packages at site/country level
18. Facilitate review and reconciliation of the study TMF on country and site levels

Qualifications:

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• 2+ years of independent on-site monitoring experience
• Experience in all types of monitoring visits, in phases I-III
• Experience in Oncology highly preferred
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel up to 75%
• Valid driver’s license (if applicable)

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