Clinical Research Associate II

This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as the primary point of contact among the project team, sponsor, and the site.

• Establish and nurture relationships with site personnel involved in the study execution.

• Prepare, execute, and report on site selection, initiation, routine monitoring, and close-out visits.

• Define, communicate, document, and achieve subject recruitment goals while adhering to project timelines at the site level.

• Ensure a timely and accurate exchange of information with trial sites concerning Adverse Events and protocol/process deviations.

• Conduct source data verification and address data queries at the site level.

• Assess and manage study risks at the site level.

• Manage the handling, usage, accounting, reconciliation, and return of Investigational Products and clinical study supplies.

• Review essential study documents and reconcile the Investigator Site File / Trial Master File (TMF) at the site level.

• Guarantee data integrity, compliance, and quality at the site level.

• Conduct preparation visits for site audits and address findings from site audits.

• Participate in study site audits and client on-site visits as necessary.

• Coordinate the flow of documents and study supplies between project teams, sites, laboratories, reviewers, and warehouses.

• Provide project-specific training for site investigators.

• Assist in the preparation of Investigator newsletters.

• Support Site Management Associates with study-specific and corporate tracking systems.

• Aid in the drafting of regulatory and ethics committee submission packages.

• Assist in the collection of IP-RED packages at the site or country level.

• Facilitate the review and reconciliation of the study TMF at both country and site levels.

⛳️ Requirements

• A college or university degree in Life Sciences or a relevant combination of education, training, and experience.

• Preference for candidates located in the Central or West Coast regions.

• A minimum of 2 years of independent on-site monitoring experience is required.

• Experience in all types of monitoring visits across phases I-III.

• Oncology experience is mandatory.

• Gastrointestinal (GI) or radio-pharmaceutical experience is preferred.

• Full working proficiency in English is required.

• Proficiency in MS Office applications is essential.

• Strong ability to plan, multitask, and thrive in a dynamic team environment.

• Excellent communication, collaboration, and problem-solving skills.

• Willingness to travel up to 75% is required.

• A valid driver’s license is necessary (if applicable).

• PSI is not currently hiring individuals who need a work visa for employment or continued employment now or in the future.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Supportive and collaborative work environment.