CRA II

CRA II (Multi-sponsor) - Colombia Home Based Updated: January 8, 2026Location: Bogota, DC, ColombiaJob ID: Position Overview: The CRA II (Multi-sponsor) supports clinical monitoring activities for multiple sponsors from a home‑based location in Colombia. The role focuses on site qualification, initiation, monitoring, and close‑out while ensuring regulatory compliance and data integrity. Job Responsibilities Performs site qualification, initiation, interim monitoring, site management activities, and close‑out visits (on‑site or remotely), ensuring compliance with regulatory, ICH‑GCP and Good Pharmacoepidemiology Practice (GPP) standards. Uses judgment to evaluate site performance and provide recommendations; escalates serious issues to the project team and develops action plans. Verifies informed consent processes, protects confidentiality, and assesses factors affecting subject safety and data integrity. Handles protocol deviations, violations, and pharmacovigilance issues. Conducts source document review, verifies required clinical data in the case report form (CRF), resolves queries, and drives completion within agreed timelines. Supports data capture via electronic data capture systems. Manages investigational product (IP) inventory, reconciliation, storage, and security, ensuring proper dispensing, administration, and handling of blinded or randomized information. Reviews the Investigator Site File (ISF), reconciles with the Trial Master File (TMF), and ensures archiving of essential documents per local guidelines. Documents all activities through letters, trip reports, and communication logs per SOPs. Enters data into tracking systems and maintains ongoing action‑item status. Manages site‑level activities and communications to meet project objectives, budgets, and timelines while adapting to changing priorities. Acts as primary liaison with study site personnel, collaborates with Central Monitoring Associates, and verifies training and compliance at assigned sites. Participates in investigator meetings, sponsor meetings, global monitoring/project staff meetings, and required clinical training sessions. Supports audit readiness, prepares for audits, and follows up on audit actions. Maintains working knowledge of ICH/GCP Guidelines, regulations, and SOPs; completes required training. Additional responsibilities include site support throughout the study lifecycle, real‑world late‑phase study design knowledge, data abstraction, sponsor collaboration, junior staff training, and proactive site suggestion. Qualifications Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience. Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. Strong computer skills and ability to adopt new technologies. Excellent communication, presentation, and interpersonal skills. Ability to manage required travel of up to 75% on a regular basis. US ONLY: As part of employment, employee may be deployed to sites requiring certain medical and personal information for facility access. Compliance with privacy and site requirements is required. EEO Statement: Syneos Health is committed to providing equal employment opportunities and is an equal opportunity employer under applicable laws. American with Disabilities Act compliance: The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate. #J-18808-Ljbffr