Are you passionate about clinical research and eager to make a significant impact in the healthcare industry? We are looking for a dedicated Clinical Research Associate II to join our team. In this role, you will be the primary site contact throughout all phases of clinical research studies, ensuring compliance with regulations and contributing to the success of our clinical trials. If you enjoy working with data and technical information, this is the perfect opportunity for you!
As a Clinical Research Associate II, you will play a crucial role in developing and maintaining strong relationships with study sites, facilitating communication, and ensuring that our research protocols are executed effectively. You will have the chance to contribute to the continuous improvement of our clinical research processes.
Key Responsibilities
- Independently manage clinical trial sites from initiation through close-out.
- Conduct on-site monitoring visits, including SQV, SIV, Routine Monitoring, and Close-Out Visits.
- Ensure compliance with protocols, ICH-GCP, sponsor requirements, and local regulations.
- Review source documents and study data to ensure quality and patient safety.
- Identify, escalate, and resolve site-related issues and risks.
- Prepare monitoring visit reports and maintain accurate study documentation.
- Maintain inspection-ready records in CTMS, eTMF, and other clinical systems.
- Build effective relationships with investigators and site personnel.
- Partner with cross-functional teams to support study delivery and site performance.
Qualifications
- Bachelor's degree
- Experience independently conducting on-site monitoring visits at hospitals and research centers.
- Experience managing sites throughout the clinical trial lifecycle.
- Experience preparing monitoring visit reports and maintaining clinical trial documentation.
- Strong knowledge of ICH-GCP, clinical trial processes, and regulatory requirements.
- Advanced English proficiency (written and spoken).
- Strong communication, organization, and stakeholder management skills.
Preferred
- Experience in CROs and/or pharmaceutical companies.
- Experience supporting audits and inspections.
- Experience across multiple therapeutic areas and clinical trial phases.
#ClinicalTrialsBR
Required Skills:
Clinical Research, Clinical Site Monitoring, Clinical Studies, Clinical Trial Documentation, Clinical Trial Management Systems (CTMS), Clinical Trials Monitoring, Data Analysis, Data Reporting, English Language, ICH GCP Guidelines, Investor Relationship Management, Regulatory Requirements