Sponsor Dedicated Clinical Research Associate II - Home-based (ITA)
Company: Syneos Health
Location: Home-based (Italy)
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization that helps accelerate the success of customers by leveraging clinical, medical affairs, and commercial insights. With over 29,000 employees in 110 countries, the company focuses on addressing modern market realities and making an impact on patient outcomes globally.
"Work Here Matters Everywhere"
Why Syneos Health?
Syneos Health is committed to the development of its people, providing career progression opportunities, technical training, and a supportive work culture. The company fosters a Total Self culture, where individuals can authentically be themselves while working in an inclusive, diverse environment. Syneos Health encourages employees to bring diverse perspectives and ideas to the table.
Role Overview
As a Sponsor Dedicated Clinical Research Associate II (CRA II), you will play a pivotal role in performing clinical monitoring and site management activities for assigned clinical trials. This includes ensuring compliance with regulatory, ICH-GCP, and protocol standards. You will manage site qualification, initiation, monitoring, and close-out visits, and provide support for both investigational products and subject recruitment activities.
Key Responsibilities
Clinical Monitoring & Site Management:
Perform site qualification, site initiation, interim monitoring, and close-out visits, ensuring compliance with ICH-GCP, regulatory guidelines, and the clinical protocol.
Assess site performance and provide recommendations for improvements; escalate serious issues as needed.
Review informed consent processes and ensure subject safety and confidentiality.
Data and Documentation Review:
Perform Source Document Reviews to verify data accuracy and completeness in Case Report Forms (CRF).
Resolve data queries and provide guidance to site staff for accurate data capture.
Ensure compliance with electronic data capture systems and ensure the proper documentation in Investigator Site Files (ISF) and Trial Master Files (TMF).
Investigational Product (IP) Management:
Oversee IP inventory, reconciliation, and ensure secure handling, dispensing, and administration of IP according to protocols.
Address issues related to blinded or randomized IP data.
Regulatory Compliance & Training:
Ensure sites comply with ICH-GCP, local regulations, and company SOPs.
Train site staff on clinical trial requirements and ensure proper documentation archiving according to local guidelines.
Attend Investigator Meetings, sponsor meetings, and provide guidance on audit readiness standards.
Support for Real World Late Phase Studies (if applicable):
In Real World Late Phase studies, support site identification, recruitment, and data collection.
Assist with chart abstraction and collaborate with sponsor affiliates and local teams.
Project & Site Communication:
Manage site-level activities, communication, and project timelines to ensure deliverables and objectives are met.
Serve as the primary liaison between study sites and project teams, ensuring that all requirements are communicated clearly and executed effectively.
Qualifications
Experience & Skills:
2+ years of clinical monitoring experience as a Certified CRA (per M.D, 15 Nov 2011).
Thorough knowledge of ICH-GCP Guidelines, Good Clinical Practice (GCP), and other regulatory requirements.
Proficiency in computer systems and ability to adapt to new technologies.
Strong communication, presentation, and interpersonal skills.
Ability to travel up to 75% regularly.
Why Work with Us?
Career Development: Syneos Health invests in your career growth with opportunities for professional development and training.
Inclusive Work Culture: The company fosters a supportive, diverse, and inclusive work environment where every individual can thrive.
Global Impact: Join a company that plays a role in bringing novel therapies to market and positively impacting patient lives across the globe.
Apply Now to be part of a dynamic team at Syneos Health, working to change lives through innovative clinical research.
Syneos Health is an equal opportunity employer and values diversity in its workforce. We encourage applicants from all backgrounds to apply and welcome transferrable skills.
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