Clinical Research Associate II

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

📋 Description

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

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

• Prepare for, conduct, 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 information sharing with trial sites regarding adverse events and any protocol/process deviations.

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

• Review and manage study risks at the site level.

• Manage, utilize, account for, reconcile, and return investigational products and clinical study supplies.

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

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

• Conduct site audit preparation visits and address any findings from site audits.

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

• Coordinate the flow of documents and study supplies among 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 in managing 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 the country and site levels.

⛳️ Requirements

• A college or university degree in Life Sciences or a comparable 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.

• Mandatory experience in Oncology.

• Preferred experience in Gastrointestinal (GI) and/or radiopharmaceuticals.

• Full working proficiency in English is required.

• Proficient in MS Office applications.

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

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

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

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

• Must not require a work visa for employment or continued employment now or in the future.

🏝️ Benefits

• Opportunities for further skill development.

• Chance to broaden therapeutic area experience.

• Potential to become an expert in clinical research.

• Flexible remote work arrangement.