Description
Syneos Health is seeking an Experienced SrCRA with oncology experience to work in a home-based setting in Romania.
As a Senior Clinical Research Associate (SrCRA), you will play a critical role in ensuring the successful execution of clinical trials. You will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits.
Key responsibilities include:
- Performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance
- Evaluating the overall performance of site and site staff, providing recommendations regarding site-specific actions, and communicating/escalating serious issues to the project team
- Maintaining a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes
- Verifying the process of obtaining informed consent, demonstrating diligence in protecting subject/patient confidentiality, and assessing factors that might affect subject/patient safety and clinical data integrity
- Conducting Source Document Review, verifying required clinical data, and applying query resolution techniques
- Managing site-level activities, communication, and timelines to ensure project objectives are met
- Collaborating with project site personnel, Lead CRA, and other stakeholders as needed
- Preparing for and attending Investigator Meetings, sponsor face-to-face meetings, and clinical training sessions
- Providing guidance on audit readiness standards and supporting preparation for audits
Requirements:
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and total rewards program.