JOB SUMMARY

The Central Monitor (CM II) will perform remote patient data review activities for Phase I-IV clinical research and/or non-interventional studies (NIS) to assess compliance with the protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements. The CM II will also ensure patient safety and data integrity using a variety of technologies. Performs all tasks routinely and independently, seeking guidance as needed.
JOB RESPONSIBILITIES

• Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
• Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data.
• Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Immediately communicates/escalates serious issues to the project team and with guidance develops action plans.
• Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action by sites, CRAs or other functional team members.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Accesses vendor systems or reports to verify the IP has been dispensed and administered to subjects/patients according to the protocol, that laboratory and other procedures have been performed, that eTMF data is current and complete.
• Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
• For assigned activities, understands project scope, budgets, and timelines; manages patient- and site-level activities to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt, with the oversight of the Lead CRA/LCMDA, to changing priorities to achieve goals/targets.
• Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings, as applicable and attends clinical training sessions according to the project specific requirements.

• 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.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Mastery of MS Excel (sorting, filtering, calculating, pivoting).
• Proficient with Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze).
• Excellent verbal and written communication skills to relate to internal stakeholders. Able to inform, influence and communicate cross-functionally.

• Strong analytical skills.
• Developing therapeutic expertise.

#LI-RB1