Oncology CRA II/Sr CRA - Single Sponsor

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

Job summary

Syneos Health is seeking a well-qualified CRA II or Senior CRA with a strong oncology background to monitor multiple sites in the US. The role covers all development phases, including early phase studies, safety, PK/PD, and dose-escalation designs.

You will perform site qualification, initiation, monitoring, and close-out visits, either on-site or remotely, ensuring regulatory and GCP compliance and robust data integrity. Travel up to 75% is expected.

Qualifications

• Bachelor’s degree or RN required; related experience acceptable.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Oncology background with CRA II or Senior CRA experience.
• Experience in early phase/first‑in‑human studies, safety, PK/PD, and dose‑escalation designs.
• Experience supporting solid tumor indications (melanoma, breast, ovarian, prostate, lung).
• Willingness to travel up to 75% and work across cross‑functional teams.
• Fluency in English and German is preferred.

Responsibilities

• Performs site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote).
• Verifies informed consent, protects patient confidentiality, and assesses safety and data integrity.
• Reviews ISF and TMF, ensures site compliance with IP labeling and regulatory requirements.
• Documents activities via letters, logs, and reports; supports recruitment and data tracking.
• Leads or supports investigator meetings and training; ensures audit readiness.

Skills

Communication skills

Team collaboration

Fast-paced environment adaptability

Travel readiness

Computer skills

Education

Bachelor’s degree or RN

Tools

GCP/ICH knowledge

Job description

Syneos Health is seeking a well-qualified CRA II or Senior CRA with a strong oncology background to monitor multiple sites in the US. The role covers all development phases, including early phase studies, safety, PK/PD, and dose-escalation designs.

You will perform site qualification, initiation, monitoring, and close-out visits, either on-site or remotely, ensuring regulatory and GCP compliance and robust data integrity. Travel up to 75% is expected.