[Remote] Clinical Research Associate II
Note: The job is a remote job and is open to candidates in USA. PSI CRO is a leading Contract Research Organization with over 30 years in the industry, focused on delivering quality services across various therapeutic indications. The Clinical Research Associate will manage monitoring tasks and ensure compliance and quality standards in clinical studies while acting as the main communication line between project teams and study sites.
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
Skills
- 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)
- Located in the Central or West Coast regions is preferred
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