Single Sponsor CRA II/Sr CRA with Oncology experience

Single Sponsor CRA II/Sr CRA with Oncology experience 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

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team and develop action plans.
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
• Demonstrate diligence in protecting the confidentiality of each subject/patient.
• Assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): assess site processes.
• Conduct source document review of appropriate site source documents and medical records.
• Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
• Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
• Verify site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Verify the IP has been dispensed and administered to subjects/patients according to the protocol.
• Verify issues or risks associated with blinded or randomized information related to IP.
• Apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Reconcile contents of the ISF with the Trial Master File (TMF).
• Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
• Support subject/patient recruitment, retention and awareness strategies.
• Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Understand project scope, budgets, and timelines for own and others’ activities in the clinical team; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate.
• Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepare for and attend Investigator Meetings and/or sponsor face to face meetings.
• Participate, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project specific requirements.
• Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
• May provide training or mentorship to more junior level CRAs.
• May perform training and sign off visits for junior CRA staff, as assigned.
• May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• A well-qualified CRA II or a Senior CRA with a strong background in oncology clinical trials.
• Early phase/first‑in‑human studies, safety, PK/PD, and dose‑escalation designs required.
• 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.
• Fluency in both English and German.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Basic level of critical thinking skills expected.
• Ability to manage required travel of up to 75% on a regular basis.

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.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

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