CRA II – Multi Sponsor

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

📋 Description

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

• Assess the performance of the site and site staff, communicate or escalate critical issues, and formulate action plans.

• Ensure informed consent processes are verified and safeguard subject/patient confidentiality.

• Evaluate subject/patient safety, the integrity of clinical data, protocol deviations, and pharmacovigilance matters.

• Review source documents and verify the clinical data entered in case report forms.

• Address queries both remotely and on-site, guide site staff, and ensure resolutions are achieved within agreed timelines.

• Utilize hardware and software for the review and capture of clinical study data; confirm compliance with electronic data capture.

• Conduct inventory, reconciliation, and storage/security reviews of investigational products as needed.

• Examine Investigator Site Files and reconcile them with Trial Master Files.

• Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and other project documents.

• Assist in subject/patient recruitment, retention, and awareness initiatives.

• Monitor observations, site status, and ensure resolution of action items.

• Oversee assigned site-level tasks and communications to align with project scope, deliverables, budgets, and timelines.

• Serve as the primary contact for study site personnel or collaborate with Central Monitoring Associates.

• Ensure training and compliance of assigned sites and project-specific team members.

• Prepare for and participate in Investigator Meetings, sponsor meetings, global monitoring/project meetings, and clinical training sessions.

• Offer site and project-level guidance for audit readiness and assist in audit preparation and follow-up activities.

• For Real World Late Phase, provide support to sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates, medical science liaisons, and local country staff, train junior staff upon request, identify out-of-scope activities, and recommend potential sites based on local expertise.

⛳️ Requirements

• 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.

• Capacity to manage travel requirements of up to 75% on a regular basis.

• Working knowledge of pertinent regulations and company SOPs/processes.

• Ability to conduct site qualification, initiation, monitoring, management, and close-out activities.

• Experience working with clinical data, source documents, medical records, CRFs, EDC systems, ISF, and TMF.

• Capability to support investigational product inventory, reconciliation, storage, dispensing, and administration verification.

• Proficiency in preparing and maintaining necessary clinical trial documentation.

• Ability to support audit readiness and follow-up actions.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Peer recognition programs.

• Comprehensive total rewards program.

• An inclusive work culture.

• Collaboration with colleagues globally.

• Flexible remote work arrangement (Remote (Pre-Approved)).