Clinical Research Associate

Clinical Research Associate

BeiGene

Remote, Germany or Austria

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, BeiGene 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 (writing and speaking).

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Travel: up to 60%

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