Senior Clinical Research Associate

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

📋 Description

• Conduct monitoring and management activities for Phase I-IV clinical research studies at designated investigative or physician locations.

• Act as the main point of contact for project site personnel throughout the entire study lifecycle, from site identification to study close-out.

• Assist with site identification and initiation processes.

• Execute site evaluations, initiation, interim monitoring, and close-out assessments either on-site or remotely.

• Carry out telephone evaluations and central monitoring from a remote location.

• Ensure adherence to regulatory requirements, ICH-GCP guidelines, and study protocols.

• Confirm that informed consent procedures are properly executed and documented.

• Evaluate risks related to patient safety and clinical data integrity, including protocol deviations and pharmacovigilance concerns.

• Review site processes and facilities, and perform Source Document Review and Source Document Verification.

• Implement query resolution strategies, oversee investigational product accountability, and review both the Investigator Site File and Trial Master File reconciliation.

• Assist in the recruitment, retention, and awareness strategies for subjects/patients.

• Input data into tracking systems and monitor observations, status, and action items until resolved.

• Analyze study and site data listings, visualizations, analytical dashboards, and reports to detect trends, risks, suspected scientific misconduct, and systematic errors.

• Gather essential documents and compile document packages necessary for site activation.

⛳️ Requirements

• Bachelor’s Degree (or equivalent) in Life Sciences, Medicine, Pharmacy, Nursing, or a related combination of education and experience.

• A minimum of 5 years of experience in clinical research and development within the pharmaceutical, biotechnology, or clinical research organization (CRO) sectors.

• At least 2 years of experience working in a CRO providing clinical research services to pharmaceutical, biotechnology, or medical device companies.

• Experience in monitoring oncology trials is required.

• Proven knowledge of the oncology therapeutic area and early-phase research design.

• Demonstrated proficiency in computer skills and a willingness to adopt new technologies.

• Strong understanding of Good Clinical Practice/ICH guidelines and other relevant regulatory requirements.

• Willingness to travel domestically and meet with sites within their organizations.

🏝️ Benefits

• Employee position.

• Remote work arrangement.

• On-site or remote monitoring activities.

• Opportunities and requirements for domestic travel.