Clinical Research Associate II - Sponsor Dedicated - UK (Fully Remote)

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Role:

The Clinical Research Associate will support the Clinical Operations department with implementation of sponsor oversight initiatives, inspection readiness, and oversight of eTMF quality in accordance with study plans, client SOPs, and applicable regulatory requirements and guidelines.

Responsibilities:

• Ensure assigned aspects of clinical studies are managed and executed in accordance with ICH GCP, regulations, the protocol, and company SOPs.
• As assigned, assist study teams with the development and/or review of study specific plans or study level documents by providing sponsor oversight perspective.
• Perform routine periodic eTMF quality/inspection readiness checks of both in-house eTMFs and CRO managed eTMFs including completeness checks, logic checks, and document quality checks. Document, escalate and track deficiencies and assist as needed with resolution.
• As requested, work with study teams to assist with study risk assessments, identifying Key Risk Indicators (KRIs), and developing and tracking mitigation strategies.
• Perform periodic reviews of study-level and program-level metrics, collate the data output and escalate key information to study teams as appropriate in a timely manner
• Perform on-site and/or remote Sponsor Oversight Visits to assess CRA and site performance.
• Assist with the development of department level procedures, processes, templates, and tools.
• May conduct Veeva eTMF training for internal and CRO study staff as requested.
• Other duties as assigned.

What we're looking for:

• Bachelor's degree in a scientific discipline or RN
• At least 2 years of clinical research experience (working in a sponsor dedicated model is a plus)
• Knowledge of pharmaceutical regulatory requirements
• Knowledge of ICH GCP guidelines and clinical study regulations
• Understands the concept of clinical study design and clinical study processes
• Prior site experience (e.g., study coordinator) and/or field monitoring experience
• Prior experience with Veeva eTMF is preferred.
• Prior experience with CTMS implementation and use is a plus.

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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