Clinical Research Associate – Germany (Monitoring & SIVs)

P95; Oregon; Remote; USD 57,000 - 74,000; Full time

Job summary

P95 and Julius Clinical have joined forces to advance global health through high‑quality epidemiological research and clinical trials. The CRA role involves site visits, monitoring, SDV/SDR, and ensuring patient safety with travel within Germany and occasionally internationally.

The ideal candidate has a Bachelor’s or Master’s degree in a life sciences field, a minimum of 2 years CRA experience, and fluency in German and English. Strong knowledge of ICH-GCP and monitoring practices is required.

Qualifications

• A Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, Biomedical Sciences, or a related field.
• A minimum of 2 years’ experience as a CRA on clinical trials.
• Solid knowledge of ICH-GCP, clinical trial regulations, and monitoring practices.
• Experience conducting independent monitoring visits across multiple sites.
• Demonstrated ability to thrive under pressure and manage multiple priorities effectively.

Responsibilities

• Performing Site Selection Visits (SSVs), Site Initiation Visits (SIVs), Monitoring Visits (MVs), and Close-Out Visits (COVs).
• Monitoring clinical trial sites according to protocol, sponsor requirements, and applicable regulations.
• Verifying data accuracy through Source Data Verification (SDV) and Source Data Review (SDR).
• Reviewing informed consent documentation and ensuring patient safety is maintained.
• Identifying, documenting, and following up on protocol deviations and study issues.
• Supporting sites with study-related questions and providing guidance on protocol requirements.
• Maintaining effective communication with investigators, study coordinators, sponsors, and internal project teams.
• Preparing high-quality monitoring reports within required timelines.
• Ensuring essential documents are complete and inspection ready.
• Contributing to risk-based monitoring activities and study quality oversight.
• Supporting study start-up, recruitment, maintenance, and close-out activities.
• Participating in investigator meetings, study team meetings, and training activities as required.

Skills

CRA experience

German and English fluency

Microsoft Office

Education

Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, Biomedical Sciences, or related field

Job description

P95 and Julius Clinical have joined forces to advance global health through high‑quality epidemiological research and clinical trials. The CRA role involves site visits, monitoring, SDV/SDR, and ensuring patient safety with travel within Germany and occasionally internationally.

The ideal candidate has a Bachelor’s or Master’s degree in a life sciences field, a minimum of 2 years CRA experience, and fluency in German and English. Strong knowledge of ICH-GCP and monitoring practices is required.