Region to cover: Northern Germany. Ideal candidate will be located in Hamburg, Bremen, or Berlin.
General Description:
- The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
- Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.
- The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
- Identify gaps and areas for improvement and propose CAPA.
- Supports start-up and provides local expertise.
- SSU experience is considered a plus
CRA activities:
- Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets
- Provides protocol and related study training to assigned sites.
- Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs
- Conducts co-monitoring visits, if required
- Completes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards and SOP
- Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations
- Ensure inspection readiness of the study and sites
- Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Attends disease indication project specific training and general CRA training as required
- Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required
- Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
- Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.
Education Required:
- BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.
- Experience in oncology global trials preferred
Other Qualifications:
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English & German (writing and speaking)
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Travel: up to 60%