Clinical Research Associate Germany (remote, 0.8-1.0 FTE)

P95; Deutschland; Vor Ort; EUR 52.000 - 75.000; Vollzeit

Zusammenfassung

P95 is expanding its epidemiology and clinical research capabilities with a focus on high‑quality trials across Europe. The role of a CRA involves on‑site monitoring, data integrity, and collaboration with investigators and sponsors to ensure compliant, timely study execution.

Ideal candidates bring ICH-GCP knowledge, 2+ years CRA experience, and fluency in German and English, willing to travel within Germany and internationally when required.

Qualifikationen

• 2+ years' CRA experience on clinical trials (IP preferred).
• Solid knowledge of ICH-GCP and trial regulations.
• Experience conducting independent monitoring visits across multiple sites.

Aufgaben

• Perform SSVs, SIVs, MVs and COVs.
• Monitor sites per protocol and sponsor requirements.
• Verify data via SDV and SDR.
• Review informed consent and ensure patient safety.
• Identify protocol deviations and study issues.
• Coordinate with investigators and sponsors.
• Prepare monitoring reports within timelines.
• Ensure essential documents are inspection-ready.
• Contribute to risk-based monitoring and QA.
• Support study start-up, recruitment, maintenance and close-out.
• Participate in investigator meetings and trainings.

Kenntnisse

ICH-GCP knowledge

Monitoring visits

Team collaboration

German fluency

English fluency

Multisite coordination

Microsoft Office

Ausbildung

Bachelor's or Master's degree in Life Sciences

Tools

Microsoft Office

Jobbeschreibung

About us

P95 and Julius Clinical have recently joined forces, bringing together two highly complementary organizations with a shared mission: advancing global health through high‑quality epidemiological research and clinical trials.

P95, founded in 2011 and headquartered in Belgium, is a global leader in epidemiology, vaccines, and infectious disease research. With offices across Europe, North America, South America, Africa, and Southeast Asia, P95 supports public health agencies, pharmaceutical companies, academic institutions, and global organizations such as WHO and the European Commission.

Our work focuses on generating timely, pragmatic, and actionable insights to improve access to safe and effective vaccines.

Julius Clinical, founded in 2008 and based in Zeist, The Netherlands, is a leading clinical CRO known for its strong scientific leadership and operational excellence. With more than 400 clinical trials conducted and over 300,000 participants enrolled worldwide, Julius Clinical specializes in central nervous system, cardio‑metabolic, renal, and rare diseases, working closely with biotech and mid‑sized pharma partners.

Together, we form a global, science‑driven organization offering an integrated portfolio of epidemiological and clinical research services.

Our teams combine deep scientific expertise, operational excellence, and a shared passion for improving healthcare outcomes.

P95 and Julius Clinical (JC) are part of the Ampersand Capital Partners portfolio, a healthcare‑focused private equity firm.

We are united by a commitment to scientific rigor, innovation, and meaningful impact and we are excited to welcome new colleagues who share our ambition to improve global health.

Responsabilities

The responsibilities for a CRA include, but are not limited to, the following:

• 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.

Experience

The ideal candidate will have

• 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 (preferably with IP).
• 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.
• Advanced problem‑solving skills and a proactive approach to challenges.
• Proven ability to plan and organize complex tasks with precision.
• Strong collaboration skills, resolving issues in a constructive and team‑oriented manner.
• A track record of maintaining high standards and accuracy in all deliverables.
• Exceptional flexibility and adaptability in dynamic environments.

Experience - you must also have these skills

• Fluency in German and English (written and spoken).
• Residence in Germany.
• Willingness and ability to travel regularly within Germany and occasionally internationally.
• Strong communication and interpersonal skills.
• Ability to work independently while being an effective team player.
• Flexible and adaptable approach to work.
• Excellent organizational skills with attention to detail and a “getting the job done” mindset.
• Client‑focused attitude and commitment to delivering high‑quality results on time.
• Proficiency in Microsoft Office and willingness to learn new software and systems.
• Cultural sensitivity and ability to collaborate across diverse international teams.