PSI CRO · 6 hours ago
Clinical Research Associate II
United States
Full-time
Remote
Entry, Mid Level
2+ years expPSI CRO is a leading Contract Research Organization with over 30 years in the industry, focusing on delivering quality services across various therapeutic indications. The Clinical Research Associate will manage monitoring tasks for clinical studies, ensuring compliance and quality standards while acting as a communication link between the project team and study sites.
Business Information SystemsHealth CarePharmaceutical
No H1B
Responsibilities
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
Qualification
Required
College/University degree in Life Sciences or an equivalent combination of education, training & experience
Must have 2+ years of independent on-site monitoring experience
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)
Preferred
Located in the Central or West Coast regions is preferred
Experience in GI preferred and/or radio-pharm experience preferred
Company
PSI CRO
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Juviler
Director Data Science
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