Job Description
Job Description
My client is a leading ophthalmic drug and device development company. They offer a comprehensive range of pre-clinical and clinical development services, leveraging their expertise and proven methods to bring innovative solutions to market. They value a diverse and inclusive workplace where kindness, excellence, joy, and scientific rigor are at the forefront of everything they do.
The Role
As a Clinical Research Associate II (CRA II), you'll play a key role in ensuring the success of my client's clinical trials. You'll build strong relationships with clinical trial sites, overseeing their adherence to protocols and regulations. Working under the guidance of senior team members, you'll be responsible for various tasks, including:
- Site Management and Monitoring: You'll collaborate with clinical trial sites throughout the entire study process, from initial setup to completion. This includes monitoring their activities to ensure compliance with protocols, Good Clinical Practices (GCP), and regulations.
- Data Quality and Subject Well-being: You'll ensure the accuracy and completeness of data collected at the sites while safeguarding the rights and safety of study participants. This involves conducting on-site visits, reviewing documentation, and addressing any issues that arise.
- Communication and Problem-Solving: You'll act as a liaison between my client and the clinical trial sites, effectively communicating on protocol adherence, recruitment, and other study-related matters. You'll also identify and resolve any performance or compliance problems that may occur.
- Technical Skills and Knowledge: You'll possess a strong understanding of clinical research protocols, GCPs, and relevant regulations. Proficiency in CTMS, EDC, and Excel is essential.
Qualifications
- Bachelor's degree with a minimum of 2 years of experience as a Clinical Research Associate or relevant experience.
- Excellent attention to detail, strong communication skills, and the ability to work independently and collaboratively.
- Proficiency in assessing protocol compliance, verifying data accuracy, and managing clinical trial documentation.
Additional Information
- This role involves up to 50% travel.
- My client is an equal opportunity employer and values diversity at their company.