Central Data Monitor

University of Colorado•Hybrid, CO

12d•$58,705 - $74,673•Hybrid

About The Position

The full-time Central Data Monitor will be a key member of the Clinical Research Support Team (CReST), which is part of the Office of Clinical Trials (OCT). CReST provides support services to clinical investigators for all activities related to the successful conduct of clinical research, from study start-up through close out. This role is crucial for translating basic science knowledge into clinically useful treatments for patients. The ideal candidate will have familiarity with clinical research terms, data capture systems, and software testing and validation. Strong time management, organizational, and communication skills are essential, as is the ability to make independent decisions and solve problems. We are looking for a collaborative, communicative, solution-oriented, organized, proactive, critical-thinking, quality-focused, passionate, and motivated individual dedicated to personal growth and advancing properly-resourced clinical trials.

Requirements

A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, computer sciences, programming, business, or a directly related field from an accredited institution.
2 years of professional level experience as clinical research coordinator, clinical research data coordinator, data manager, or similar position.
Experience with interventional clinical trials.
Oncology research experience.
Experience programming and/or designing EDC databases, medical coding dictionaries, and quality control processes.
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Demonstrated commitment and leadership ability to advance diversity and inclusion.
Exceptional accountability, organization, and time management skills.
Ability to interpret a clinical research protocol, including objectives, endpoints, and key variables.
Comprehension of study documentation and archival processes.
Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint).
Knowledge of data management.
Ability to problem solve and prioritize tasks.
Knowledge of Good Clinical Practice, FDA Regulations (particularly 21 CFR Part 11) in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions.
Some knowledge of basic human anatomy, physiology, medical terminology.

Nice To Haves

Three or more years of clinical research experience, including experience with Phase I, and investigator-initiated research.
Experience working with Advarra EDC and REDCap.
Epic or other EMR experience.
Experience implementing software release life cycle (SRLC).
Experience working with investigator-initiated research.
Biostatistics or statistical analysis experience.
Technical or procedure writing experience.
Familiarity with Industry-standards regarding clinical research data methodologies.

Responsibilities

Develop, test, release, and maintain electronic case report forms (eCRFs), EDC calendars, and other data capture tools in compliance with SOPs and 21 CFR Part 11 regulations.
Design and program study eCRFs considering Quality by Design best practices.
Review clinical study documents (protocol, study plans) and meet with investigators and teams to identify necessary forms and fields.
Make revisions to database forms based on feedback from PIs, monitors, statisticians, and clinical teams.
Write eCRF Completion Guidelines.
Train study site staff on data entry procedures.
Develop and validate standardized form templates for adaptation to specific protocols.
Write and deploy study-specific Data Management Plans, including procedures for database validation, performance checks, access roles, testing, release, and data delivery.
Define and create automatic queries/alerts to ensure data quality.
Define procedures for periodic checks of database functionality and data validity/completeness, and maintain records.
Create and run reports for data review by other entities.
Provide data and analytics related to monitoring trends to the Monitoring team and stakeholders.
Manage database lock review, tasks, and timelines.
Collaborate with stakeholders to develop and revise SOPs and implementation strategies for Advarra EDC.
Maintain and utilize up-to-date knowledge of relevant regulations (e.g., 21 CFR Part 11), guidelines, standards, and policies.
Proactively identify applicable tests, clinical procedures, and practices for protocol and EDC implementation.
Explain and defend best practices and required procedures to various audiences.
Facilitate help requests related to Advarra EDC.
Relay timely information and project updates to PIs, study staff, CReST leadership, and other stakeholders.
Respond to study team questions and requests for help or changes to eCRFs.
Develop budget estimates for EDC builds.
Effectively communicate all EDC updates to the Monitoring team.
Accurately track billable time dedicated to EDC/eCRF build and data management duties.
Exhibit professionalism and accountability.
Engage with teammates and support a collaborative team culture.
Assist CReST managers and leadership in metric, tool, and process development for continuous quality improvement.
Assist with regulatory submissions or other tasks for CReST-facilitated human subjects research projects, if assigned.
Perform other duties as assigned by the manager.