Senior Clinical Research Associate

BeOne continues to grow at a rapid 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, collaborative, and most importantly, reputed company our passionate interest in fighting cancer.

General Description:

The Senior CRA executes clinical trial protocols at clinical trial sites and monitors clinical trials in accordance to ICH guidelines and GCP, local regulations, and applicable SOPs. Performs monitoring activities reputed company to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials reputed company the assigned region.

The Senior CRA is responsible for performing quality reputed company site visits and collaborating closely with the Clinical Operations Study reputed company to ensure study timelines are adhered to and required quality standards are maintained, mentor and manage CRAs.

Essential Functions of the job:

The following functions may apply based on study and program requirements;

• Mentor and manage junior staff and Clinical Research Associates
• Acts as the escalation reputed company person for CRA(s) with site reputed company issues and concerns
• Review RFPs and SOWs to ensure adequate CRO monitoring and relevant CRO procedures are correctly reflected
• Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit) per monitoring plan and applicable SOPs
• Conducts co-monitoring visits, if required
• Conducts Quality reputed company Visits (QOV) or other monitoring visits, as requested
• Completes monitoring visit/ QOV reports timely
• Documents monitoring activities appropriately following ICH-GCP and reputed company standards
• Assists with investigator/site identification
• Provides protocol and reputed company study training to assigned sites
• Manages site performance by tracking regulatory submissions, recruitment, case report reputed company (CRF) completion, and data query resolution
• Collaborates with Clinical Operations Study reputed company and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Supports the Clinical Operations Study reputed company to manage the clinical study sites, as required
• Establish regular lines of communication with sites and reports site reputed company and issues to Clinical Operations
• Support with study plans, development of presentations to support milestones and reputed company key findings
• Authors or reviews monitoring plan and recruitment plan
• Helps to reputed company and reviews site specific recruitment materials and tools
• Attends disease indication project specific training and general CRA training as required
• Facilitate site audits and/or inspections
• Evaluates the quality and reputed company of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate
• Attends regional investigator meeting and site booster visits, as required
• reputed company and support as needed the Clinical Study reputed company with clinical data review of listings for completeness during key submission times

Supervisory Responsibilities:

• reputed company mentoring and reputed company of junior staff and Clinical Research Associates
• reputed company necessary training to CRAs, support site visits as needed
• reputed company training plan(s) for CRAs and reputed company team members
• Co-monitoring with reputed company CRAs if needed to ensure reputed company and address site reputed company concerns
• Assist with the identification of development opportunities for junior team members

Education Required:

• BS in a relevant scientific discipline and minimum of 5 year of relevant Clinical Operations experience and minimum of 3 years of monitoring experience.
• Experience in oncology global trials preferred

Computer Skills: Efficient in reputed company Word, reputed company, and Outlook

Other Qualifications:

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• 3-5 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Fluent in English (writing and speaking) and Polish

Travel: up to 40-70% time

Global Competencies

reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits reputed company and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• 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, merit, and business need.

Originally posted on Himalayas