Senior Clinical Research Associate

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

📋 Description

• Ensure effective protocol-level implementation of SMM deliverables for designated sites/studies, encompassing study initiation, execution, and closure.

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

• Proactively identify and address site-related issues impacting timelines and create alternative solutions.

• Maintain updated clinical trial management systems with site-specific details.

• Provide expertise regarding local regulatory and legal requirements.

• Guarantee timely payment processing for designated sites/studies in accordance with clinical study agreements and local obligations.

• Ensure that assigned sites are prepared for audits and inspections.

• Offer guidance on pre-audit preparations for GCP compliance.

• Prepare for and follow up on site audits/inspections, contributing to CAPA development.

• Mentor and coach CRAs, providing insights into their professional growth.

• Act as the country point of contact for CROs when designated.

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

• Identify training requirements and standardize/facilitate training solutions for SMM monitors globally when appointed.

• Assist with onboarding, consolidate lessons learned, define best-practice training curricula, and keep abreast of upcoming changes.

• Serve as the primary contact in the country/district for assigned studies when designated.

• Update Impact/Tesla with country-level details and planning timelines when assigned.

• Act as a global representative for one or more studies when appointed.

• Perform remote data reviews of assigned sites/studies in accordance with relevant plans, SOPs/WIs, timelines, and objectives when designated.

• Provide continuous feedback on investigator/site performance.

• Foster professional and collaborative relationships with peers 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 perspectives and facilitate informed decision-making.

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

• Ability to adapt and remain flexible in response to changing requirements.

• Resourceful and innovative thinker.

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

• Strong organizational and planning skills.

• High degree of flexibility in a fast-paced environment with multiple projects and deadlines.

• Demonstrated commitment to business ethics and integrity.

• Compliance with federal and relevant local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and monitoring plans.

🏝️ Benefits

• Employees have the option to work remotely.

• Equal opportunity employer.

• Commitment to integrity, innovation, transforming lives, and community service.