Clinical Research Associate II
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Job Description
Clinical Research Associate II monitoring oncology clinical trials for PSI, a contract research organization. Managing site visits, data integrity, regulatory documents, and investigator communications.
Responsibilities:
- Act as the main line of communication between the project team, sponsor, and the site
- Build and maintain relationships with site staff involved in study conduct
- Prepare, conduct, and report site selection, initiation, routine monitoring, and close-out visits
- Define, communicate, record, and meet subject recruitment targets and follow project timelines at site level
- Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
- Perform source data verification and follow up on data queries at site level
- Review and manage study risks at site level
- Ensure proper handling, accountability, reconciliation, and return of Investigational Products and clinical study supplies
- Review essential study documents and reconcile Investigator Site File / TMF at site level
- Ensure 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
- Coordinate documents and study supplies between project team, site, laboratories, reviewers, and warehouse
- Conduct project-specific training of site investigators
- Support preparation of Investigator newsletters
- Assist Site Management Associates with study-specific and corporate tracking systems
- Support preparation of 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
- Located in the Central or West Coast regions is preferred
- 2+ years of independent on-site monitoring experience
- Experience in all types of monitoring visits, in phases I-III
- Experience in Oncology mandatory
- GI experience 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)
- PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future
Benefits:
- Employees can work remotely
- Opportunity to further develop skills, widen therapeutic area experience, and become an expert in clinical research
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