Description
Syneos Health is seeking a Central Monitor II to perform remote patient data review activities for Phase I-IV clinical research and/or non-interventional studies. The successful candidate will review patient data listings and visualizations to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues, and illogical/inaccurate/missing data.
Responsibilities:
- Review protocol, critical data, and process, safety, and data integrity risks related to protocol execution
- Review patient data listings and visualizations via analytical dashboards and/or reports
- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
- Immediately communicate/escalate serious issues to the project team and develop action plans
- Document observations noted during reviews and write queries, protocol deviations, or action items as necessary
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- Access vendor systems or reports to verify IP dispensing and administration, laboratory procedures, and eTMF data
- Document completion of activities via tracking, reporting, and/or other required project documents
- Understand project scope, budgets, and timelines; manage patient- and site-level activities to ensure project objectives, deliverables, and timelines are met
- Adapt to changing priorities to achieve goals/targets
- Prepare for and attend Investigator Meetings and/or sponsor meetings
Qualifications:
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
- Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements
- Good computer skills and ability to embrace new technologies
- Mastery of MS Excel (sorting, filtering, calculating, pivoting)
- Proficient with Analytical Data Visualization Tools
- Excellent verbal and written communication skills
- Strong analytical skills
- Developing therapeutic expertise
- <10% travel (limited to trainings, investigator meetings)