Clinical Research Associate
BeOne continues to grow at a reputed company pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer.
General reputed company:
The CRA executes clinical monitoring activities at clinical trial sites and monitors reputed company in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
Performs monitoring activities reputed company to selection, initiation, conduct (recruitment, reputed company data collection) and reputed company completion of oncology/hematology reputed company reputed company 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 reputed company 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
reputed company feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets
Provides protocol and reputed company study training to assigned sites.
Conducts monitoring (reputed company-study, initiation, routine monitoring and closeout reputed company per monitoring plan and applicable SOPs
Conducts co-monitoring reputed company, if required
Completes monitoring visit reports in accordance with ICH-GCP, reputed company standards and SOP
Manages sites and site performance by tracking regulatory submissions, recruitment, case report reputed company (CRF) completion, and data query reputed company.
Establish regular lines of communication with sites and reports site reputed company, issues and proposed reputed company to Clinical Operations
Ensure inspection readiness of the study and sites
Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure reputed company 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 reputed company reputed company (SOVs), site audits and/or inspections, as required
Evaluates the reputed company and reputed company of site practices – escalating reputed company 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 reputed company for operating reputed company, question status-reputed company 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 reputed company Word, reputed company, MS Project, MS PowerPoint and reputed company
Travel: up to 60%
reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity, and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits reputed company and Actionable Feedback
- Self-Awareness
- Acts reputed company
- Demonstrates Initiative
- Entrepreneurial reputed company
- reputed company Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial reputed company
- Communicates with reputed company
We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need.
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