Senior Clinical Research Associate

This is a fully remote position, open to applicants in Taiwan.

📋 Description

• Oversee the effective execution of SMM deliverables at designated sites/studies, encompassing study initiation, implementation, and closure.

• Conduct and supervise monitoring visits, site assessments, site selection and activation, monitoring closure, and reporting on visits.

• Proactively identify and address site-related issues that may impact timelines and devise alternative solutions.

• Keep clinical trial management systems updated with site-specific data.

• Provide expertise on local regulatory and legal requirements.

• Ensure prompt payment execution for the designated sites/studies in accordance with clinical study agreements and local regulations.

• Guarantee compliance with federal and local regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards.

• Stay informed about changing local regulations, guidelines, and policies.

• Ensure readiness for audits and inspections at assigned sites.

• Offer guidance on pre-audit GCP activities and prepare/follow up on site audits and inspections, including input into CAPA preparation.

• Mentor and coach CRAs, contributing to their professional development.

• Act as the country liaison for CROs when designated.

• Engage in or lead global/local task forces and initiatives.

• Recognize training needs and standardize/facilitate training solutions for SMM monitors when assigned.

• Assist with onboarding, consolidate lessons learned, create best-practice training materials, and stay informed about upcoming changes.

• Serve as the country/district study contact and update country-level information in Impact/Tesla when assigned.

• Represent globally for assigned studies as needed.

• Perform remote data reviews of assigned sites/studies in accordance with IDRP, Monitoring Plan, SOP/WI, timelines, and objectives when assigned.

• Provide continuous feedback on investigator/site performance.

• Foster professional and collaborative relationships with colleagues and site monitors.

⛳️ Requirements

• Bachelor's degree or equivalent in a health-related field (e.g., Medical, Scientific, Nursing, Pharmacy) is preferred.

• At least 5 years of experience in site monitoring.

• Strong analytical and critical thinking abilities to assess complex issues from various angles and support informed decision-making.

• Exceptional interpersonal skills with the capability to communicate effectively and persuasively.

• Ability to adapt and be flexible in response to evolving requirements.

• Resourceful and creative problem-solver.

• Proven track record as a proactive and positive team player.

• Strong organizational and planning skills.

• High adaptability to a dynamic environment with multiple projects and deadlines.

• Proven integrity and business ethics.

🏝️ Benefits

• Remote work options available for employees.

• Equal opportunity employer.

• Commitment to integrity, innovation, life transformation, and community service.