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Clinical Research Associate Ii

Company

BeiGene

Address , Remote
Employment type FULL_TIME
Salary $90,500 - $120,500 a year
Expires 2023-12-01
Posted at 8 months ago
Job 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:
The CRA will assume the role of a primary CRA. The CRA will conduct site visits (i.e., PSSV, SIV, IMV, COV) and function as the site manager. The CRA is responsible to build and maintain relationships with key site personnel and ensure an effective line of communication.
The CRA will also monitor data quality and patient safety through monitoring and site education.
CRAs are to complete all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
Essential Functions of the job:
  • Attend disease indication and/or project specific training, as required
  • Provide protocol and related study training to assigned clinical study sites
  • Maintain oversight of site performance by tracking metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issues
  • Perform Serious Adverse Event (SAE) reconciliation and work with study sites to resolve discrepancies
  • Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).
  • Perform study-specific training with project team
  • Communicate site performance to the Clinical Study Team (CST)
  • Provide audit/inspection preparation support to clinical study sites and ensure quality issues or findings are followed to resolution, as neededAssist with other assigned clinical responsibilities within scope of role, as required
  • Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
  • Attend regional investigator meeting and site booster visits, as required
  • Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation
  • Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices
  • Develop collaborative relationships with investigative sites, and study vendors
Computer Skills:
  • Efficient in Microsoft Word, Excel, PowerPoint and Outlook
  • Familiar with industry CTMS and data management systems
Other Qualifications:
  • Fluent in English (writing and speaking)
  • Excellent communication and interpersonal skills
  • Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
  • Excellent organizational skills and ability to prioritize and multi-task
Supervisory Responsibilities:
  • Provides mentoring/support to CRAs for CRA related topics
  • Provides site level management for established protocols and portfolio under general supervision
  • Co-monitoring with CRAs and support site visits, as needed
Education Required:
  • BS/BA in a relevant scientific discipline and minimum of 2+ years of relevant Clinical Operations experience, and minimum of 1+ years of monitoring experience.
  • Experience in global oncology trials preferred.
Travel:
Up to 70% travel
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.
Salary Range: $90,500.00 - $120,500.00 annually
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
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, 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.