CRA II

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

📋 Description

• Conduct site qualification, initiation, interim monitoring, site management, and close-out visits either on-site or remotely.

• Assess site and staff performance, offering site-specific recommendations and action plans.

• Ensure informed consent processes, maintain subject/patient confidentiality, uphold safety standards, ensure protocol compliance, and protect clinical data integrity.

• Evaluate site processes, perform source document reviews, verify CRF data, resolve queries, and guarantee compliance with electronic data capture.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, administration, labeling, import, and return processes.

• Review and reconcile Investigator Site Files with Trial Master Files while ensuring the archiving of essential documents.

• Document monitoring activities through letters, trip reports, communication logs, and necessary project documents.

• Assist in the recruitment, retention, and awareness strategies for subjects/patients.

• Monitor observations, site status, and action items until resolution.

• Manage assigned site-level activities and communications to achieve project objectives, deliverables, and timelines.

• Act as a liaison with study-site personnel, ensuring training and compliance for the site/project team.

• Prepare for and participate in investigator and sponsor meetings, global project meetings, and clinical training sessions.

• Facilitate audit readiness, preparation, and follow-up actions.

• For Real World Late Phase: provide site support throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and recommend potential sites.

⛳️ Requirements

• A Bachelor’s degree or RN in a relevant field or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other applicable regulatory standards.

• Proficient computer skills and a willingness to adopt new technologies.

• Strong communication, presentation, and interpersonal abilities.

• Capability to manage necessary travel of up to 75% regularly.

• Working knowledge of ICH/GCP Guidelines, pertinent regulations, and company SOPs/processes.

• Completion of assigned training as required.

• Ability to perform site qualification, initiation, monitoring, management, and close-out activities on-site or remotely.

• Proficiency in supporting clinical study data review, capture, and query resolution.

• Competence in managing site-level activities, communications, project scope, budgets, and timelines.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations, when appropriate, under the Americans with Disabilities Act.