Position: Clinical Research Associate II
Company Overview:
Syneos Health® is a premier integrated biopharmaceutical solutions organization committed to accelerating customer success. We leverage unique clinical, medical, and commercial insights to deliver outcomes that meet the complexities of the modern market.
Our Clinical Development model prioritizes both the customer and the patient. We continually strive to simplify our processes, making Syneos Health easier to collaborate with and a great place to work.
Join us in either a Functional Service Provider partnership or a Full-Service environment, where you’ll collaborate with dedicated problem solvers, innovating together to help our clients achieve their objectives. We are agile and passionate about expediting the delivery of therapies to improve lives.
Why Syneos Health?
We are dedicated to the growth and development of our employees, offering career advancement opportunities, supportive management, technical training, and recognition programs. Our "Total Self" culture encourages authenticity and fosters an environment where diverse perspectives are valued, creating a workplace where everyone feels they belong.
Key Responsibilities:
Conduct site qualifications, initiations, interim monitoring, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards, ICH-GCP, and study protocols. Use your judgment to evaluate site performance, escalate significant issues, and develop action plans as necessary.
Ensure that informed consent processes are properly conducted and documented, while safeguarding patient confidentiality and assessing factors affecting patient safety and data integrity.
Implement the Clinical Monitoring/Site Management Plan (CMP/SMP) by:
Manage investigational product (IP) inventory and ensure adherence to protocols regarding dispensation and administration. Address any issues related to blinded or randomized information.
Review the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF) and ensuring compliance with local archiving regulations.
Document activities through confirmation letters, trip reports, and other required project documentation, supporting patient recruitment and retention strategies.
Understand project scope, budgets, and timelines, managing site-level communications to achieve project objectives effectively.
Act as a primary liaison with study site personnel, ensuring that all assigned site team members are trained and compliant.
Prepare for and participate in Investigator Meetings and global project staff meetings, as well as clinical training sessions.
Maintain audit readiness and assist with audit preparations and follow-up actions.
Additional Responsibilities for Real World Late Phase (RWLP):
Qualifications:
Get to Know Syneos Health:
In the last five years, we have worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, contributing to over 200 studies across 73,000 sites and 675,000+ trial patients.
No matter your role, we encourage initiative and challenging the status quo in a dynamic environment. Learn more about us at Syneos Health.
Additional Information:
This job description is not exhaustive, and responsibilities may evolve as needed. Syneos Health reserves the right to assign additional tasks. Equivalent experience and qualifications will be considered.
We are committed to complying with the Americans with Disabilities Act, providing reasonable accommodations as necessary to support our employees and applicants in performing essential job functions. If you’re interested in this role but may not meet every qualification, we encourage you to apply—your unique skills might be just what we need!
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Copenhagen |Hungary :
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