Job Description
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 follows 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. Ensures 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
19. College/University degree in Life Sciences or an equivalent combination of education, training & experience
20. Located in the Central or West Coast regions is preferred
21. Must have 2+ years of independent on-site monitoring experience
22. Experience in all types of monitoring visits, in phases I-III
23. Experience in Oncology mandatory & GI preferred and/or radio-pharm experience preferred.
24. Full working proficiency in English
25. Proficiency in MS Office applications
26. Ability to plan, multitask and work in a dynamic team environment
27. Communication, collaboration, and problem-solving skills
28. Ability to travel up to 75%
29. Valid driver’s license (if applicable)
Additional Information
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.