Clinical Research Associate, CRA I

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

📋 Description

• Serve as the primary contact and site manager throughout all stages of a clinical research study.

• Establish robust relationships with sites and maintain these connections through every phase of the trial.

• Carry out clinical study site management and monitoring tasks in accordance with the International Conference on Harmonization / Good Clinical Practices.

• Acquire a comprehensive understanding of the study protocol and associated procedures.

• Engage in and provide input on site selection and validation processes.

• Conduct site visits, which may include validation visits, initiation visits, monitoring visits, and closeout visits.

• Liaise with Investigators and site personnel regarding issues related to protocol execution, recruitment, retention, and regulatory documentation.

• Identify, evaluate, and address site performance, quality, or compliance issues.

⛳️ Requirements

• At least 2 years of direct experience in site monitoring within the bio/pharma/CRO sector.

• Proficient in local languages and English, both verbal and written.

• Solid understanding and practical knowledge of clinical research and the phases of clinical trials.

• Familiarity with Global and Country/Regional Clinical Research Guidelines.

• Practical knowledge of Good Documentation Practices.

• Proven ability in Site Management, including oversight of site performance and patient recruitment.

• Demonstrated high-level monitoring skills with independent professional judgment.

• Competent IT skills, including proficiency in MS Office and various clinical IT applications on computers, tablets, and mobile devices.

• Capability to comprehend and analyze data/metrics and respond appropriately.

• Willingness to travel domestically and internationally approximately 65%-75% of the time.

🏝️ Benefits

• Health insurance.

• Opportunities for professional development.