Clinical Research Associate

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

📋 Description

• Act as the main liaison between investigational sites and the sponsor.

• Perform site selection, initiation, routine monitoring, and close-out visits.

• Ensure compliance of sites with ICH-GCP, standard operating procedures, and regulations.

• Manage documentation within CTMS and eTMF systems.

• Assist in tracking site staff training and maintaining compliance records.

• Monitor patient safety and guarantee timely reporting of adverse events (AE), serious adverse events (SAE), and protocol deviations (PQC).

• Facilitate subject recruitment and retention at the site level.

• Supervise drug accountability and manage proper storage, return, or disposal.

• Address data queries and ensure timely, high-quality data entry.

• Document site progress and escalate any risks or issues to the clinical team.

• Track site budgets and ensure prompt site payments as necessary.

• Partner with Clinical Trial Assistants (CTAs), Lead Trial Managers (LTMs), Clinical Trial Managers (CTMs), and other cross-functional colleagues.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a related field, or a qualified Registered Nurse (RN).

• Must be eligible to work in the United States without requiring visa sponsorship.

• At least 2 years of on-site monitoring experience in the pharmaceutical or CRO sector.

• Prior experience in monitoring Oncology clinical trials, including prostate and lung cancer, as well as HemeONC studies.

• Strong knowledge of ICH-GCP and local regulatory requirements.

• Familiarity with CTMS and eTMF clinical systems.

• Willingness and ability to travel up to 50% for on-site monitoring visits throughout the Western region.

• Preference for candidates residing in Phoenix, Arizona, near major hub airports.

• Excellent communication, problem-solving skills, and ability to work collaboratively in a team environment.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Medical, dental, and vision coverage where applicable.

• Retirement and pension plans available.

• Life insurance and disability coverage provided.

• Employee assistance programs and wellbeing resources offered.

• Opportunities for learning and development through structured training and career pathways.