Clinical Research Associate III

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

📋 Description

• Oversee 10–15 investigational sites independently from initiation to closure.

• Conduct Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV) following the Monitoring Plan.

• Ensure adherence to protocols, Monitoring Plans, Standard Operating Procedures (SOPs), ISO 14155, FDA regulations, and local laws.

• Carry out Source Data Verification (SDV)/Source Data Review (SDR), review informed consent processes, and monitor Adverse Events (AE) and Serious Adverse Events (SAE).

• Take ownership of assigned investigator sites and guarantee effective site management and performance.

• Establish and nurture relationships with Principal Investigators and site personnel.

• Provide training, guidance, and support to site staff.

• Address queries, offer updates, and facilitate issue resolution.

• Ensure data integrity, prompt query resolution, and site adherence to compliance measures.

• Identify potential risks and prepare for audits and inspections.

• Collaborate with Data Management, Clinical, and Project Management teams.

• Participate in Investigator and/or Coordinator meetings.

• Mentor junior Clinical Research Associates (CRAs) and offer insights on problem-solving and best practices.

• Contribute to training efforts and review work to foster team development and uniformity.

• Assist upper management by providing study updates, reporting escalations, and engaging in operational decision-making.

⛳️ Requirements

• Minimum of 5 years of experience as a Clinical Research Associate (CRA).

• Significant experience in the medical device sector.

• Preferred background in cardiovascular/TEVAR medical devices.

• Comprehensive understanding of Good Clinical Practice (GCP) and FDA regulatory standards.

• Capability to work autonomously while effectively managing multiple tasks and prioritizing activities across various sites and study requirements.

• Willingness to travel 50–75% of the time.

• Proven ability to manage 10–15 investigational sites from initiation to closure.

• Knowledge of ISO 14155, FDA regulations, and local compliance requirements.

• Experience in conducting SIV, IMV, and COV monitoring visits.

• Familiarity with SDV/SDR, informed consent review, and AE/SAE oversight.

🏝️ Benefits

• Travel requirement of 50–75% is indicated, but no specific benefits or additional compensation details are provided in the job posting.