Our client, a radiopharmaceuitcal company developing medicines for cancer patients, is launching a large phase 3 trial, and is looking for monitoring support on the trial.
Key Responsibilities:
- Conduct site initiation, routine monitoring, and closeout visits in accordance with study protocols, GCP, and regulatory requirements.
- Perform site qualification, initiation, and training activities to ensure compliance with study protocols, SOPs, and regulatory guidelines.
- Review essential documents and maintain study files to ensure completeness, accuracy, and regulatory compliance.
- Monitor subject enrollment, data collection, and adverse event reporting to ensure protocol compliance and patient safety.
- Build strong relationships with investigational sites, investigators, and study staff to facilitate effective communication and collaboration.
- Identify and escalate study-related issues, deviations, and risks to appropriate stakeholders for resolution.
- Prepare monitoring reports, track study progress, and ensure timely resolution of data queries to maintain data integrity and quality.
- Assist in regulatory submissions, inspections, and audits as needed.
Qualifications:
- Bachelor's degree in life sciences, nursing, or related field; advanced degree preferred.
- Minimum of 2 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical, biotechnology, or CRO industry.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements governing clinical research.
- Excellent organizational, communication, and interpersonal skills with the ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in clinical trial monitoring techniques, data management systems, and Microsoft Office Suite.
- Willingness to travel domestically and internationally as needed.
If you are a proactive and detail-oriented professional looking to expand your career in clinical research, we invite you to apply for this exciting opportunity. Join us in our mission to drive innovation and improve patient outcomes through cutting-edge clinical research.
