Senior Clinical Research Associate

The role

You will monitor and own the progress of clinical studies at investigative sites. You will ensure studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and applicable regulations. You will coordinate activities to set up and monitor studies including identifying investigators and preparing regulatory submissions.

What you will do

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards
• Coordinate all necessary activities required to set up and monitor a study
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits

Required qualifications

• Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline
• At least 6 months of experience as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Site management or equivalent experience in clinical research
• Excellent communication and organizational skills
• Team player
• Evidence of a client focused approach
• Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment
• Fluency in English and German
• Experience in oncology

Nice to have

• Study start up activities experience
• CAR-T or FIH studies - phase III
• Medical device experience

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship

About the company

Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO. The company combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics solutions.