Clinical Research Associate (CRA).

at  PANDA

For a leading company within drug development, laboratory and lifecycle services we are looking for a Clinical Research Associate (CRA). You will and play a vital role in delivering life-changing therapies to patients worldwide. As part of our team, you’ll have the opportunity to contribute to groundbreaking clinical trials across more than 100 countries, ensuring the quality and accuracy of data that leads to healthier outcomes for communities everywhere. If you are driven by excellence and looking for a dynamic career in clinical research, this role is for you.

Responsibilities

• Monitor clinical trial sites: Ensure protocol compliance and regulatory adherence through on-site and remote visits. Apply a risk-based monitoring approach to identify site failures, and recommend corrective and preventive actions.
• Data accuracy and compliance: Perform Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) reviews to ensure data integrity. Monitor investigational products by reviewing inventory and records.
• Issue resolution: Report deficiencies and follow up on corrective actions, ensuring all issues are addressed promptly. Maintain regular communication with trial sites to monitor the resolution process and data accuracy.
• Site initiation and closeout: Manage the setup and closeout of clinical trial sites, ensuring compliance with all protocols and regulations. Oversee the retrieval of trial materials and completion of essential documents.
• Collaboration and communication: Facilitate effective communication between investigative sites, the sponsor company, and internal teams through written, oral, and electronic correspondence. Participate in investigator meetings and site qualification processes.
• Administrative tasks: Complete administrative responsibilities such as expense reporting and timesheets in a timely manner. Assist with investigator payments and maintain up-to-date study systems.

Requirements

• Educational background: Bachelor’s degree in a life sciences field or Registered Nursing certification, or an equivalent academic qualification.
• Driver’s license: A valid driver’s license is required.
• Strong knowledge of medical terminology and therapeutic areas.
• Ability to understand and maintain knowledge of ICH GCP guidelines and regulatory requirements.
• Excellent verbal and written communication skills in both Romanian and English.
• Proficiency in Risk-Based Monitoring concepts and processes.
• Strong computer skills, including expertise in Microsoft Office and the ability to learn specialized software.

• Monitor clinical trial sites: Ensure protocol compliance and regulatory adherence through on-site and remote visits. Apply a risk-based monitoring approach to identify site failures, and recommend corrective and preventive actions.
• Data accuracy and compliance: Perform Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) reviews to ensure data integrity. Monitor investigational products by reviewing inventory and records.
• Issue resolution: Report deficiencies and follow up on corrective actions, ensuring all issues are addressed promptly. Maintain regular communication with trial sites to monitor the resolution process and data accuracy.
• Site initiation and closeout: Manage the setup and closeout of clinical trial sites, ensuring compliance with all protocols and regulations. Oversee the retrieval of trial materials and completion of essential documents.
• Collaboration and communication: Facilitate effective communication between investigative sites, the sponsor company, and internal teams through written, oral, and electronic correspondence. Participate in investigator meetings and site qualification processes.
• Administrative tasks: Complete administrative responsibilities such as expense reporting and timesheets in a timely manner. Assist with investigator payments and maintain up-to-date study systems