Clinical Research Associate II

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
• Located in Central or West Coast preferred*
• 2 years of independent on-site monitoring experience required
• 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 drivers 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.

For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Remote Work :

Yes

Employment Type :

Full-time