Full-Time Clinical Research Associate II
PSI CRO is hiring a remote Full-Time Clinical Research Associate II. The career level for this job opening is Experienced and is accepting Remote, undefined based applicants remotely. Read complete job description before applying.
PSI CRO
Job Title
Clinical Research Associate II
Posted
Career Level
Full-Time
Career Level
Experienced
Locations Accepted
Remote, undefined
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Job Details
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:
- Act as the main line of communication between the project team, sponsor, and the site
- Build and maintain a good relationship with the site staff involved in the study conduct
- Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
- Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
- Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
- Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
- Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
- Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
- Ensures quality (data integrity and compliance) at site level
- Conduct site audit preparation visits and resolve site audit findings
- Participate in study site audits and client onsite visits, as required
- Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
- Conduct project-specific training of site investigators
- Support preparation of Investigator newsletters
- Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
- Support preparation of draft regulatory and ethics committee submission packages
- Support collection of IP-RED packages at site/country level
- Facilitate review and reconciliation of the study TMF on country and site levels
Located in Central or West Coast preferred
2+ years of independent on-site monitoring experience required
Experience in all types of monitoring visits, in phases I-III
Experience in Oncology mandatory & GI preferred and/or radio-pharm experience 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)
Skills
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Clinical Research Associate II at PSI CRO is
14th of December 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Remote, undefined
] applicants. .
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