Senior Clinical Research Associate (SCRA)

BeiGene

Department:  Clinical Operations

Reports To: Manager/Associate Director/Director

Education Required: 

BS in a relevant scientific discipline and 3-4 years of relevant Clinical Operations experience.

General Description:

The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials within the country.

The CRA is responsible to deliver data within timelines and required quality standard, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.

Essential Functions of the job:

  • Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require
  • Conducts co-monitoring visits, if required
  • Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
  • Attends onboarding-, disease indication and project specific training and general CRA training as required
  • Documents monitoring activities appropriately following ICH-GCP and BeiGene standards
  • Conducts Quality Oversight Visits (QOV), as requested
  • Completes monitoring visit/ QOV reports timely
  • Assists with investigator/site identification
  • Assists site to prepare Ethics Committee submissions
  • Facilitates clinical trial site contract and budget negotiation
  • Manages site queries and communications
  • Assists in managing clinical trials, if required
  • Establishes regular lines of communication with sites and COMs
  • Provides protocol and related study training to assigned sites
  • Evaluates the quality and integrity of site practices – escalating quality issues as appropriate
  • Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
  • Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
  • Performs additional task as assigned

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:

  • Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
  • Excellent communication and interpersonal skills
  • Excellent organizational skills and ability to prioritize and multi-task
  • Fluent in English (writing and speaking)

To apply for this job email your details to us.careers@beigene.com

Apply using webmail: Gmail / AOL / Yahoo / Outlook