Clinical Research Associate II

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

📋 Description

• Serve as the primary communication link among the project team, sponsor, and study site.

• Foster and maintain strong relationships with site personnel involved in the execution of the study.

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

• Ensure that subject recruitment targets are established, communicated, recorded, and achieved on time, while adhering to project timelines at the site level.

• Guarantee accurate and timely communication with trial sites regarding Adverse Events and deviations from protocol/process.

• Conduct source data verification and follow up on data queries at the site level; assess and manage study risks on-site.

• Ensure appropriate handling, usage, accountability, reconciliation, and return of all Investigational Products and clinical study supplies at the sites.

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

• Ensure quality (data integrity and compliance) at the site level.

• Conduct site audit preparation visits and address site audit findings.

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

• Ensure the seamless flow of documents and study supplies between the project team, site, and Central/Regional Laboratory/Central Reviewer/Warehouse.

• Conduct project-specific training for site investigators.

• Assist in the preparation of Investigator newsletters.

• Support Site Management Associates in maintaining study-specific and corporate tracking systems at the site level.

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

• Support the collection of 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 an equivalent 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, particularly in phases I-III.

• Mandatory experience in Oncology, with preference for Gastrointestinal and/or radio-pharmaceutical experience.

• Full working proficiency in English is required.

• Proficient in MS Office applications.

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

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

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

• Valid driver's license (if applicable).

🏝️ Benefits

• This role presents an excellent opportunity for you to enhance your skills.

• Expand your experience across various therapeutic areas.

• Become an expert in the field of clinical research.