Clinical Research Associate II

PSI CRO

About The Position

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

Requirements

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)

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