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.

• Foster and sustain relationships with site personnel involved in study execution.

• Prepare, conduct, and document site selection, initiation, routine monitoring, and closure visits.

• Establish, communicate, record, and achieve subject recruitment objectives while adhering to project timelines at the site level.

• Ensure prompt and accurate communication with trial sites regarding Adverse Events and deviations from protocols/processes.

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

• Evaluate and manage risks associated with the study at the site level.

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

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

• Ensure data integrity and compliance at the site level.

• Conduct preparation visits for site audits and resolve any findings from those audits.

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

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

• Provide project-specific training to 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 draft regulatory and ethics committee submission packages.

• Assist in 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 mix 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.

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

• Oncology experience is mandatory.

• Experience in Gastrointestinal (GI) and/or radiopharmaceuticals is preferred.

• Full working proficiency in English is required.

• Proficiency in MS Office applications is necessary.

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

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

• 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 in the future.

🏝️ Benefits

• Full-time employment.

• Remote work flexibility.

• Opportunities for skill enhancement.

• Chance to broaden therapeutic area experience.

• Opportunity to become an expert in clinical research.