Clinical Research Associate II Job at PSI CRO, Remote

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  • PSI CRO
  • Remote

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.

Job Description



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 

Qualifications



 

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • 2+ years of independent on-site monitoring experience
  • Experience in all types of monitoring visits, in phases I-III
  • Experience in Oncology and GI/GU highly 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)

 

Additional Information



This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

Job Tags

Full time, Contract work,

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