Sponsor Dedicated Cra Ii - Uk Wide Travel - Must Have Uk Monitoring Experience

2+ years

Not Disclosed

Remote, USA

10 Dec. 6, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Sponsor-Dedicated CRA II (Home-Based, UK)

Company: Syneos Health®

About Syneos Health®
Syneos Health® is a global leader in biopharmaceutical solutions, driven by innovation and committed to accelerating customer success. With a collaborative Clinical Development model, we place the patient and customer at the center of everything we do. Our 29,000+ employees across 110 countries share a passion for delivering therapies that transform lives.

At Syneos Health, you’ll join a team of problem-solvers dedicated to simplifying and streamlining processes. Whether partnering through a Functional Service Provider or Full-Service environment, our team’s agility ensures timely delivery of clinical solutions.

Why Join Us?

Career Growth: Supportive line management, skill development, and career progression opportunities.
Culture: Our Total Self culture fosters inclusivity, belonging, and authenticity, ensuring employees feel valued.
Global Impact: Diversity of thought and perspective drives innovation and creates meaningful change.

Job Responsibilities:
As a Sponsor-Dedicated CRA II, you will:

Site Management:
- Perform site qualification, initiation, monitoring, and close-out visits.
- Ensure compliance with regulatory, ICH-GCP, and protocol standards.
- Assess site performance and address/escalate critical issues.
Patient Safety:
- Verify informed consent processes and document adherence.
- Assess subject/patient safety and clinical data integrity.
Data Review:
- Conduct Source Document Review and verify case report form (CRF) accuracy.
- Address data queries and ensure resolution within project timelines.
Compliance & Documentation:
- Review Investigator Site File (ISF) and Trial Master File (TMF) for completeness.
- Maintain accurate records of site activities and communicate effectively with site personnel.
Investigational Product (IP) Management:
- Oversee IP inventory, storage, and administration compliance.
- Ensure adherence to local regulations for IP labeling and handling.
Training & Support:
- Train site personnel and ensure project-specific compliance.
- Support subject/patient recruitment and retention strategies.
Project Collaboration:
- Act as a primary liaison with study sites and collaborate with Central Monitoring Associates.
- Participate in investigator meetings and global clinical monitoring/project staff sessions.

Qualifications:

Education: Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
Experience: Proven monitoring experience in CRO/Pharma settings with a strong grasp of Good Clinical Practice/ICH Guidelines and applicable regulations.
Skills:
- Proficient with technology and data management tools.
- Strong communication, presentation, and interpersonal skills.
- Ability to handle travel requirements (up to 75%).

About Syneos Health:
Our commitment to excellence is reflected in our partnerships with 94% of all FDA-approved novel drugs over the past five years. We’ve conducted 200+ studies across 73,000 sites, involving 675,000+ trial patients.

Disclaimer:
Tasks and responsibilities may evolve based on business needs. Syneos Health values inclusivity and adheres to all employment regulations, including providing reasonable accommodations under the Americans with Disabilities Act.

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Sponsor Dedicated Cra Ii - Uk Wide Travel - Must Have Uk Monitoring Experience

Job Description

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