Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate at AbbVie, a biopharmaceutical company developing innovative medicines and health solutions. Overseeing clinical study sites, monitoring, regulatory compliance, audits, and CRA mentoring in Taiwan.
Responsibilities:
- Ensure successful protocol-level execution of SMM deliverables for assigned sites/studies, including study start-up, execution, and close-out
- Conduct and oversee monitoring visits, site evaluations, site selection and activation, monitoring close-out, and visit reports
- Anticipate and identify site issues affecting timelines and develop alternative solutions
- Maintain current clinical trial management systems with site-specific information
- Provide local regulatory and legal requirement expertise
- Ensure timely payment execution for assigned sites/studies according to clinical study agreements and local requirements
- Ensure adherence to federal and local regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards
- Stay current on evolving local regulations, guidelines, and policies
- Ensure audit and inspection readiness of assigned sites
- Advise on pre-audit GCP activities and prepare/follow up on site audits and inspections, including input into CAPA preparation
- Coach and mentor CRAs and provide input into their development
- Serve as country point of contact for CROs when assigned
- Participate in or lead global/local task forces and initiatives
- Identify training needs and standardize/facilitate training solutions for SMM monitors when assigned
- Support onboarding, consolidate lessons learned, develop best-practice training curricula, and maintain awareness of upcoming changes
- Serve as a country/district study contact and update country-level information in Impact/Tesla when assigned
- Act as global representative for assigned studies when assigned
- Conduct remote data review of assigned sites/studies according to IDRP, Monitoring Plan, SOP/WI, timelines, and objectives when assigned
- Provide ongoing feedback on investigator/site performance
- Build professional and collaborative relationships with peers and site monitors
Requirements:
- Bachelor's or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred
- Minimum 5 years of site monitoring experience
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making
- Excellent interpersonal skills with the ability to communicate persuasively and with clarity
- Flexibility and adaptability to changing requirements
- Resourcefulness and creativity
- Demonstrated proactive and positive team player
- Strong planning and organizational skills
- High level of flexibility in a dynamic environment with competing projects and deadlines
- Demonstrated business ethics and integrity
Benefits:
- Employees can work remotely
- Equal opportunity employer
- Commitment to operating with integrity, driving innovation, transforming lives, and serving the community
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