CRA II/Sr CRA – Moldova, Macedonia

This is a fully remote position, open to applicants in Moldova, +1 more country.

📋 Description

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

• Ensure compliance with regulatory standards, ICH-GCP/GPP guidelines, and study protocols.

• Assess the performance of sites and site staff, offer recommendations, escalate critical issues, and create action plans.

• Verify informed consent, ensure subject/patient safety, and maintain the integrity of clinical data.

• Evaluate site processes, perform source document reviews, and review medical records.

• Validate clinical data in case report forms and assist in resolving queries both remotely and on-site.

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

• Oversee investigational product inventory, reconciliation, storage, dispensing, and administration reviews as necessary.

• Review Investigator Site Files and ensure they are reconciled with the Trial Master File.

• Document monitoring activities through letters, trip reports, communication logs, and other project documentation.

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

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

• Manage site-level activities and communications to align with project scope, deliverables, objectives, and timelines.

• Collaborate with study site personnel and Central Monitoring Associates.

• Ensure that assigned sites and project-specific site team members are adequately trained and compliant.

• Participate in investigator meetings, sponsor meetings, global project meetings, and clinical training sessions.

• Support audit readiness, prepare for audits, and follow up on related actions.

• For Real World Late Phase: provide site support from identification to close-out, conduct chart abstraction and data collection, collaborate with sponsor affiliates, medical science liaisons, and local country staff, train junior staff when necessary, identify out-of-scope activities, and recommend potential sites.

⛳️ 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 relevant regulatory requirements.

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

• Exceptional communication, presentation, and interpersonal abilities.

• Capability to manage extensive travel of up to 75% on a regular basis.

• Understanding of pertinent regulations and company SOPs/processes.

• Proficient in clinical monitoring, site management, source document review, case report forms, electronic data capture, and trial documentation.

• For Real World Late Phase: awareness of local requirements for real world late phase study designs.

• Equivalent experience, skills, and/or education may be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Recognition among peers.

• Comprehensive total rewards program.

• A culture that promotes authenticity and inclusion through Total Self initiatives.

• Commitment to diversity, equity, and belonging initiatives.