PSI CRO
Pharmaceuticals
ClinicalResearchAssociateII
Neural analysis suggests this role is
optimal for mid candidates.
“Clinical Research Associate II at PSI CRO. Skills: monitoring, clinical studies, quality standards, communication, collaboration, problem-solving. 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”
What You'll Achieve.
delivering quality and on-time services; maintaining the highest quality standards in the industry; Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level; Ensures quality (data integrity and compliance) at site level
Industry & Context.
problem-solving skills
Ability to travel up to 75%, Valid driver’s license (if applicable), PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
What They're Looking For.
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, Full working proficiency in English, Proficiency in MS Office applications, Ability to plan, multitask and work in a dynamic team environment, Ability to travel up to 75%, Valid driver’s license (if applicable)
Nice to Have
Located in the Central or West Coast regions is preferred, GI preferred, radio-pharm experience preferred
What You'll Do.
Act as the main line of communication between the project team
Build and maintain a good relationship with the site staff involved in the study conduct
and report site selection
routine monitoring and close-out visits
Ensure that subject recruitment targets are timely defined
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 review and manage study risks on a site level
Ensure proper handling
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
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
How You'll Work.
Team & Collaboration
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; collaboration; Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse; Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
Communication Scope
Communication; Communication skills
Process & Methodology
Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level, manage study risks on a site level, Ability to plan, multitask and work in a dynamic team environment
Full Job Description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. 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 prepara
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