Clinical Research Associate II
Company: Syneos Health
Location: Home-based or as specified
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical, and commercial insights into actionable outcomes. The company is dedicated to simplifying and streamlining work processes, making Syneos Health both an easier company to work with and for.
With a global presence of over 29,000 employees across 110 countries, Syneos Health puts the customer and patient at the center of everything they do. They aim to bring therapies to market faster and make a meaningful difference in people's lives.
"Work Here Matters Everywhere"
Why Syneos Health?
Syneos Health is passionate about the development and progression of its people. The company offers career development programs, technical and therapeutic area training, and a supportive work culture. Syneos Health is committed to fostering an inclusive environment where employees can be their authentic selves, and diversity of thoughts and perspectives is embraced.
Role Overview
As a Clinical Research Associate II (CRA II), you will be responsible for overseeing the progress of clinical trials and ensuring regulatory compliance. This includes site qualification, initiation, monitoring, and close-out visits (both on-site and remotely). You will play a key role in supporting the success of clinical trials by managing site-level activities and helping to drive project timelines.
Key Responsibilities
Clinical Monitoring & Site Management:
Perform site qualification, site initiation, interim monitoring, and close-out visits, ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practices (GPP), and clinical protocols.
Evaluate site performance and provide recommendations for corrective actions.
Ensure proper informed consent is obtained, protecting subject confidentiality and safety.
Data and Documentation Review:
Conduct Source Document Reviews to verify accuracy and completeness of clinical data.
Resolve data queries remotely and on-site and provide guidance to site staff.
Ensure compliance with electronic data capture and documentation protocols.
Investigational Product (IP) Management:
Oversee IP inventory, reconciliation, and verify storage and security.
Ensure that the investigational product is dispensed and administered correctly, following the protocol.
Address issues related to blinded or randomized IP.
Regulatory Compliance & Training:
Ensure adherence to regulations and company SOPs, and ensure sites are following local regulatory requirements.
Train site staff on clinical trial procedures and regulatory compliance.
Attend Investigator Meetings and clinical monitoring/project staff meetings.
Project & Site Communication:
Manage site activities and communication, ensuring project objectives and timelines are met.
Act as a liaison between site staff and the project team, ensuring effective communication and troubleshooting any issues that arise.
Real World Late Phase Study Support (if applicable):
Support site lifecycle from site identification to close-out, focusing on real-world late-phase studies.
Conduct chart abstraction activities and collaborate with local teams to ensure effective data collection.
Qualifications
Experience & Skills:
Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
2+ years of clinical research experience in a CRA role.
Thorough understanding of Good Clinical Practice (GCP), ICH Guidelines, and other relevant regulatory requirements.
Proficiency in using clinical trial management systems and electronic data capture tools.
Excellent communication and interpersonal skills to work effectively with sites and project teams.
Ability to travel up to 75% regularly.
Why Work with Us?
Career Growth: Syneos Health is committed to career development through continuous learning and professional advancement.
Inclusive Culture: The company fosters a culture where diversity is celebrated, and every employee feels they belong.
Global Impact: Work with a company that has contributed to the success of 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products.
Apply Now to join a passionate team dedicated to accelerating the delivery of life-changing therapies.
Syneos Health is an equal opportunity employer and values diversity in its workforce. They encourage individuals from all backgrounds to apply.
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