Clinical Research Associate II
2 weeks ago
Clinical Research Associate II is a key role in our organization, responsible for ensuring the smooth conduct of clinical trials. As a CRA II, you will be working closely with site staff, investigators, and other stakeholders to ensure compliance with regulatory requirements and good clinical practice.
Key Responsibilities:- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Verify the process of obtaining informed consent and assess factors that might affect subject/patient safety and clinical data integrity.
- Conduct source document review, verify required clinical data, and apply query resolution techniques remotely and on-site.
- May perform investigational product inventory, reconciliation, and reviews storage and security.
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
- 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 is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE
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