Clinical Research Associate II

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

📋 Description

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

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

• Plan, execute, and document site selection, initiation, routine monitoring, and close-out visits.

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

• Ensure timely and precise information exchange with trial sites regarding Adverse Events and deviations from the protocol/process.

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

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

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

• Evaluate essential study documents and reconcile the Investigator Site File / TMF at the site level.

• Guarantee data integrity and compliance at the site level.

• Execute site audit preparation visits and address findings from site audits.

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

• Manage the distribution of documents and study supplies among project teams, sites, laboratories, reviewers, and warehouses.

• Provide project-specific training to site investigators.

• Assist in the preparation of Investigator newsletters.

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

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

• Facilitate the collection of IP-RED packages at the site/country level.

• Assist in 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.

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

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

• Oncology experience is mandatory.

• GI experience preferred, and/or radio-pharmacy experience is a plus.

• Full working proficiency in English is required.

• Proficient in MS Office applications.

• Capability to plan, multitask, and collaborate effectively 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).

• Must not require a work visa for employment or continued employment now or at any future time.

🏝️ Benefits

• Full-time employment.

• Remote work arrangement.

• Opportunities for skill enhancement.

• Chance to broaden therapeutic area experience.

• Opportunity to become a clinical research expert.