Senior Oncology CRA – Germany (Remote/On-site)

Syneos Health, Inc.; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Syneos Health, Inc. is seeking an experienced Clinical Research Associate (CRA) focused on oncology to join its single-client team.

The role requires monitoring visits, site qualification, and ensuring adherence to ICH-GCP, with on-site or remote work options within Germany and travel expectations up to 75%. Ideal candidates hold a Bachelor's degree or RN, have German and English language proficiency, and demonstrate strong communication and computer skills.

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.
• Previous monitoring experience in Germany.
• Phase I experience would be a plus.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Fluency in German and proficient in English.
• 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 and located in the North-Eastern region of the country.

Responsibilities

• Performs 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.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
• Per the CMP/SMP: Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies CRF data accuracy via source documents.
• May perform IP inventory, reconciliation and reviews storage and security.
• Routinely reviews the ISF for accuracy, timeliness and completeness and reconciles with TMF.
• Documents activities via letters and logs; supports recruitment, retention and tracking.
• Understands project scope, budgets, and timelines; manages site-level activities to meet objectives.
• May act as liaison with project site personnel and train site staff.

Skills

Fluency in German

Proficient in English

Excellent communication

Strong computer skills

Education

Bachelor’s degree or RN

Job description

Syneos Health, Inc. is seeking an experienced Clinical Research Associate (CRA) focused on oncology to join its single-client team.

The role requires monitoring visits, site qualification, and ensuring adherence to ICH-GCP, with on-site or remote work options within Germany and travel expectations up to 75%. Ideal candidates hold a Bachelor's degree or RN, have German and English language proficiency, and demonstrate strong communication and computer skills.