CRA II – Sponsor-dedicated

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

📋 Description

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

• Ensure adherence to regulatory requirements, ICH-GCP/GPP standards, and protocol compliance.

• Assess site and staff performance, providing recommendations for site-specific actions.

• Communicate and escalate significant issues to the project team while formulating action plans.

• Verify informed consent processes and safeguard subject/patient confidentiality.

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

• Conduct reviews of source documents and confirm the accuracy and completeness of clinical data.

• Address queries both remotely and on-site, guiding site staff towards resolution.

• Ensure compliance with electronic data capture protocols.

• Manage investigational product inventory, reconciliation, and storage/security assessments as required.

• Review and reconcile Investigator Site Files with Trial Master Files.

• Document monitoring activities through necessary project documentation and tracking systems.

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

• Oversee site-level activities, communications, deliverables, and timelines.

• Collaborate with study site personnel to ensure that assigned sites and project-specific staff are trained and compliant.

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

• Aid in audit readiness and preparation for audits, including follow-up actions.

• In the context of 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 as needed, identify out-of-scope activities, and recommend potential sites based on local knowledge.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or a comparable 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 skills.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition programs.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations, when appropriate, to assist employees or applicants with essential job functions.