Clinical Data Monitor

SUMMARY OF POSITION

The Senior (or Clinical Data Monitor) will be responsible for compliance monitoring across CorEvitas clinical registries.

The Senior Clinical Data Monitor (or Clinical Data Monitor) serves as the go-to resource for data collection best practices for all other registry stakeholders including study personnel at participating clinical sites.

This individual will ensure quality, accuracy, and integrity of registry data throughout the full lifecycle of multiple registries through utilization of a risk-based, remote, and onsite monitoring approach.

Travel may be expected up to 70% of the time in the United States and Canada to perform source data audits at clinical registry sites.

ESSENTIAL FUNCTIONS

• Acts as a data collection and recording specialist, ensuring that data collection for each registry is performed in compliance with the approved protocol, applicable regulations, and data management SOPs.
• Verifies that data entered into registry Case Report Forms (CRFs) are accurate, complete, and clinically consistent across time.
• Generates queries in the clinical Electronic Data Capture (EDC) systems for missing, inconsistent, or erroneous data, and provides guidance to site staff and collaborates with Registry Managers to resolve queries within the expected timeframe.
• Tracks and documents the status and outcome of data review activities.
• Prepares comprehensive reports for remote monitoring events and onsite audits including follow-up letters to the clinical registry sites.
• Identifies and communicates data management issues to Registry Managers and recommends site retraining.
• Performs onsite audits of source data and source medical records.
• Provides information and documentation in response to Subscriber requests or audits.
• Participates in paper CRF and EDC system User Acceptance Testing (UAT)
• Other duties as assigned.
• Ability to work independently or exercise judgment when necessary.
• Excellent written and interpersonal skills and the ability to build effective relationships both internally and with clinical registry site staff.
• Knowledge of medical terminology and human subject research
• Strong organizational, IT and administration skills with attention to detail
• Proficient with SharePoint, collaborating and co-authoring of documents.
• Ability to learn new software programs such as electronic data capture software, which will be taught on the job.

Minimum Qualifications

• Minimum of 2 years of experience with clinical trials / medical research a Clinical Research Associate (CRA) or equivalent in a pharmaceutical or biotech environment.
• Bachelor’s degree in related field.
• Experience with quality assurance or clinical trial auditing / monitoring, and / or good clinical practice.
• Thorough knowledge of ICH GCP and FDA guidelines
• Experience using EDC systems.

Preferred Qualifications

• BA / BS in medical research or scientific discipline, health care, or other appropriate discipline.
• Certified Clinical Research Associate (CCRA) credentialing.

WORK ENVIRONMENT

• Remote position
• Must be able to remain in a stationary position for an extended period.
• Travel within the US and Canada up to 70% of the time.

Job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.

Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.