Senior CRA/CRA II in oncology trials

Syneos Health; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Syneos Health is seeking a Senior CRA/CRA II for oncology trials. The role focuses on on-site monitoring, data integrity, and regulatory compliance across all development phases, including early phase studies.

Strong CTMS experience (Siebel, Veeva Vault, Medidata, Oracle Clinical/Clinical One) and multilingual English/German skills are highly preferred. You will work within a fast-paced environment with a mission-driven team.

Qualifications

• Experience in oncology trials across all phases.
• Hands-on expertise with on-site monitoring and CTMS.
• Proven ability to produce accurate trip reports and manage IP accountability.
• Multilingual in English and German is preferred.

Responsibilities

• Monitor oncology trials across all development phases, including early phase studies.
• Ensure regulatory compliance, ICH/GCP adherence, and robust data integrity.
• Generate and review comprehensive monitoring visit reports and trip reports.
• Operate CTMS platforms and manage trial documentation to timelines.

Skills

Oncology expertise

Solid tumor knowledge

On-site monitoring

Trip report writing

English and German

Tools

Siebel CTMS

Veeva Vault CTMS

Medidata CTMS

Oracle Clinical/Clinical One

Job description

Senior CRA/CRA II in oncology trials

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

For one of our clients we are looking for a well-qualified CRA with a strong background in oncology clinical trials across all phases of development, including early phase/first in human studies, safety, PK/PD, and dose escalation designs.

The ideal candidate will have hands on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer, and will be comfortable operating in fast paced development environments where quality execution supports accelerated timelines and regulatory submissions. Prior exposure to investigational products involving Toll Like Receptor (TLR) pathways, PARP1 inhibitors, or Werner helicase protein is desirable but not required.

This role requires demonstrated proficiency in traditional on site monitoring models, including full source data verification, investigational product accountability, and strict adherence to ICH/GCP and regulatory requirements. Candidates must have a proven track record of managing visit activities efficiently while producing accurate, comprehensive, and timely monitoring visit and trip reports. Extensive experience working within CTMS platforms such as Siebel CTMS, Veeva Vault CTMS, Medidata CTMS, Oracle Clinical/Clinical One, or similar systems is expected. Multilingual capabilities, particularly fluency in English German are strongly preferred.

Successful candidates will bring a mission driven and intellectually curious mindset, with a strong sense of ownership and a collaborative, adaptable approach to clinical operations. We value individuals who demonstrate professionalism, attention to detail, reliability, and ethical decision making, along with strong communication and teamwork skills. The ability to thrive in a high urgency environment, leverage digital tools effectively, maintain a customer focused approach with sites and stakeholders, and proactively identify and resolve issues is essential to ensuring trial integrity and success.

Required Technical Skills:

• Oncology Expertise: all phases of development
• Indication-Specific Knowledge: solid tumor
• Traditional Monitoring Model: Solid skills and proficiency in on-site monitoring, full source data verification, IP accountability and regulatory compliance.
• Trip Report Writing: Proven track record in producing accurate, comprehensive, and timely monitoring visit reports, with extensive experience using any CTMS platform (such as Siebel CTMS, Veeva Vault CTMS, Medidata CTMS, Oracle Clinical/Clinical One, or similar systems)
• Additional Skills: multilingual - English and German

Culture-Specific & Desired Soft Skills:

• Mission-focused & intellectually curious: a collaborative mindset with a passion for pushing boundaries and tackling complex challenges to create solutions that matter.
• Collaborative and adaptable mindset: strong professionalism (ethics, detail focus, reliability) with excellent collaboration (communication, teamwork, building trust) and adaptability to a fast-paced environment (sense of urgency for the mission), emphasizing quality, digital fluency (CTMS, eTMF, remote tools) and customer service to sites and sponsors, all while maintaining a proactive, problem-solving mindset to ensure trial integrity and success.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

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.