Clinical Trial Associate

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Location :
San Mateo, California

Expiry Date :
Sun, 25 Apr 2021 23:59:59 GMT

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Description :
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General_Description * Key Clinical Operations support role; ensures that delegated components of clinical trials are executed to expected and specified quality standards * Builds basic knowledge of clinical trials operations and scientific principles and objectives of BeiGene s clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows when to involve / collaborate with others * Learns best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations Qualifications Education Required: BS in a relevant scientific discipline and 2 + years of relevant Clinical Operations experience. Essential_Functions_Of_The_Job * Ensures understanding of clinical trial protocols and site specifications and the scientific/medical objectives of the clinical trials * Verifies that data collected in trials is consistent with protocols * Reviews monitoring reports; checks for adherence to trial metrics; and assesses sites against clinical trial protocol specifications. Quality * Ensures patient enrollment activities are within protocol guidelines * Day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to Project Manager or senior Clinical Operations staff * Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for BeiGene studies * Fully understands the need for and importance of being inspection ready and diligently follows BeiGene Clinical Operations SOPs; identifies and communicates if there are gaps * Accountable for ensuring that agendas for meetings are clear and distributed in advance; takes comprehensive and precise minutes for internal and external meetings. Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking * Develops knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of these activities * Provides study level information to enable accurate and efficient supply of clinical product to the sites * Adheres to Clinical Operations processes and SOPs * Actively participates in the development of department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations Timelines * Communicates and coordinates with senior Clinical Operations staff/ management to ensure accurate and comprehensive completion of documents by Regulatory Affairs; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines * Under the guidance and direction of the Project Manager and/or Clinical Operations management, interfaces with other BeiGene functions to coordinate relevant and timely exchange of information / materials to support clinical trials delivery within the drug development process * Ensures patient enrollment activities are conducted in a timely manner Budget * Assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations Supervisory_Responsibilities * N/A Competencies Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction. Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information. Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others. Adaptability Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events. Technical_Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others. Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. Problem_Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Project_Management – Communicates changes and progress; Completes projects on time and budget. Computer Skills: Efficient in Microsoft Word, Excel, and Outlook Other_Qualifications Travel: potential travel of up to 10% We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Show moreShow less