- 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
- Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation
- Develop collaborative relationships with investigative sites, and study vendors
- Track enrollment status reports to ensure study sites stay on track to meet enrollment goals
- Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status are kept current by the monitoring team
- Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
- Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed
- Perform study-specific training with project team
- Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data
- Perform Serious Adverse Event (SAE) reconciliation and work with study sites and CRAs to resolve discrepancies
- Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines
- Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to manage site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites within established protocols and portfolio under general supervision
- Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).
- Provide support for study sites, and CRAs with audits/inspections preparation/responses and quality issues, as needed, and follow-through with audit/inspection findings to resolution as it related to involved CRA staff.
- Assist with other assigned clinical responsibilities within scope of role to provide best practice and/or support to junior clinical staff
- Provides site level management for established protocols and portfolio under general supervision
- Provides mentoring/support to CRAs for study related topics
- Identification of development opportunities and provides necessary training to for junior team members as needed
- Co-monitoring with CRAs and support site visits, as needed
Competencies:Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. - Efficient in Microsoft Word, Excel, PowerPoint and Outlook
- Familiar with industry CTMS and data management systems
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- Minimum of 4-6 years of relevant Clinical Operations experience
- Minimum of 3-4 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-taskTravel: up to 40-60% time
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Senior Clinical Research Associate - Emeryville, United States - BeiGene
Description
General Description:The SCRA is primarily a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to day clinical study activities, departmental tasks, and provides mentoring to other CRA team members within established protocols and portfolio under general supervision.
Proactively seeks opportunities to lead and drive improvements to optimize effectiveness and efficiencies within the Site Management group as well as within the greater Americas region.
Essential Functions of the job:
Supervisory Responsibilities:
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:
Education Required:BS/BA in a relevant scientific discipline and minimum of 4-6 years of relevant Clinical Operations experience, and minimum of 3-4 years of monitoring experience.
Experience in global oncology trials preferred.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
