Clinical Research Associate

Kurz zusammengefasst

Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO. The company focuses on revolutionizing cancer treatment through precision medicine, using biomarkers to tailor treatments to specific mutations. They are currently hiring Clinical Research Associates (CRAs) at various seniority levels to join their team in Germany. The main responsibilities of a Clinical Research Associate at Precision for Medicine include monitoring and overseeing the progress of clinical studies at investigative sites. This involves ensuring that studies are conducted, recorded, and reported according to protocols, SOPs, ICH-GCP, and all applicable regulations and standards. CRAs will coordinate all necessary activities to set up and monitor a study, such as identifying investigators, preparing regulatory submissions, and conducting pre-study and initiation visits. To qualify for this role, candidates must have a graduate or postgraduate degree in a scientific or healthcare discipline. Additionally, at least six months of experience as a CRA in a CRO or pharmaceutical/biotech industry is required, along with site management or equivalent experience in clinical research. Fluency in both English and German is essential, as is the ability to travel domestically, which may include overnight stays constituting up to 50-60% travel commitment. Experience in oncology is also required. Nice-to-have skills include experience in study start-up activities, CAR-T or FIH - phase III, and medical device experience. The role offers a supportive environment with direct line management, reasonable travel requirements, and the opportunity to have a significant impact on study outcomes. The team at Precision for Medicine values input from all members, ensuring that ideas are nurtured and contribute to positive change within the company. What the role asks for: - A graduate or postgraduate degree in a scientific or healthcare discipline. - At least 6 months of experience as a CRA in a CRO or pharmaceutical/biotech industry. - Site management or equivalent experience in clinical research. - Fluency in English and German. - Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment. - Experience in oncology. - Nice-to-have: Experience in study start-up activities. - Nice-to-have: Experience in CAR-T or FIH - phase III. - Nice-to-have: Medical device experience.