Department: Clinical Operations
Reports To: Clinical Study Manager/Associate Director/Director
BS in a relevant scientific discipline and minimum of 1 year of relevant Clinical Operations experience.
The 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 related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials within the assigned region.
The CRA is responsible for performing quality oversight site visits and collaborating closely with the Clinical Operations Study Lead to ensure study timelines are adhered to and required quality standards are maintained.
Essential Functions of the job:
The following functions may apply based on study and program requirements;
- Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit) per monitoring plan and applicable SOPs
- Conducts co-monitoring visits, if required
- Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Collaborates with Clinical Operations Study Lead and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Authors or reviews monitoring plan and recruitment plan
- Attends disease indication project specific training and general CRA training as required
- Facilitate site audits and/or inspections
- Documents monitoring activities appropriately following ICH-GCP and BeiGene standards
- Conducts Quality Oversight Visits (QOV) or other monitoring vists, as requested
- Completes monitoring visit/ QOV reports timely
- Assists with investigator/site identification
- Manages site queries and communications
- Supports the Clinical Operations Study lead to manage the clinical study sites, as required
- Establish regular lines of communication with sites and reports site progress and issues to Clinical Operations
- Provides protocol and related study training to assigned sites
- Evaluates the quality and integrity 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
- Helps to develop and reviews site specific recruitment materials and tools
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
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- 1-2 years or more (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)
Travel: up to 50-70% time