Clinical Research Associate II

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

📋 Description

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

• Establish and nurture relationships with site personnel involved in 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 timely and accurate communication regarding Adverse Events and protocol/process deviations with trial sites.

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

• Assess and manage study-related risks at the site level.

• Guarantee the proper handling, accountability, reconciliation, and return of Investigational Products and clinical study materials.

• Review essential study documents and ensure the reconciliation of the Investigator Site File / TMF at the site level.

• Maintain data integrity and compliance at the site level.

• Prepare for site audits and address any findings that arise.

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

• Coordinate documentation and study supplies among the project team, site, laboratories, reviewers, and warehouse.

• 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 preparation of regulatory and ethics committee submission packages.

• Assist in collecting IP-RED packages at the site/country level.

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

⛳️ Requirements

• Bachelor's degree in Life Sciences or a comparable combination of education, training, and experience.

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

• Minimum of 2 years of independent on-site monitoring experience.

• Familiarity with all types of monitoring visits across phases I-III.

• Oncology experience is mandatory.

• GI experience and/or radio-pharm experience is preferred.

• Full proficiency in English.

• Competence in MS Office applications.

• Capacity to plan, multitask, and thrive in a dynamic team setting.

• Strong communication, collaboration, and problem-solving abilities.

• Willingness to travel up to 75% of the time.

• Valid driver's license (if applicable).

• PSI is not hiring individuals who will require a work visa for employment, now or in the future.

🏝️ Benefits

• Employees have the flexibility to work remotely.

• Opportunity for skill enhancement, expansion of therapeutic area experience, and development into a clinical research expert.