Clinical Research Associate II
reputed company
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 reputed company on delivering reputed company and on-time services across a reputed company of therapeutic indications.
Job reputed company
As a Clinical Research Associate at PSI you will enjoy a reputed company of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest reputed company standards in the industry.
You will:
reputed company 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 reputed company-out reputed company
Ensure that subject recruitment targets are reputed company defined, communicated, recorded and met, and project timelines are followed at site level
Ensure accurate and reputed company information reputed company with trial sites on Adverse Events and protocol/process deviations
reputed company reputed company data verification and follows up on data queries at site level; review and manage study risks on a site level
Ensure reputed company handling, use, accountability, reconciliation, and return of reputed company 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 reputed company (data reputed company and compliance) at site level
Conduct site audit preparation reputed company and resolve site audit findings
Participate in study site audits and reputed company onsite reputed company, as required
Ensure the reputed company 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 reputed company
Qualifications
College/University degree in Life Sciences or an equivalent combination of education, training & experience
Located in the Central or reputed company Coast reputed company is preferred
Must have 2+ years of independent on-site monitoring experience
Experience in reputed company types of monitoring reputed company, 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%
reputed company reputed company’s license (if applicable)
Additional Information
This is a great opportunity for you to reputed company reputed company your skills, widen your therapeutic area experience, and become an expert in clinical research.
For this position, PSI is not hiring individuals who require work reputed company for employment or reputed company employment now or anytime in the reputed company.
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