Central Data Monitor

Job Summary:

The full-time CReST Central Data Monitor will be a key member of the Clinical Research Support Team (CReST). CReST is part of the Office of Clinical Trials (OCT), a partnership between the Office of the Vice Chancellor of Research (OVCR) and the School of Medicine (SOM). CReST provides a la carte support services to clinical investigators for all activities related to the successful conduct of clinical research, from study start-up through close out. This is the cornerstone to translate basic science knowledge into clinically useful treatment for patients.

Position Fit:

The ideal candidate will have familiarity with clinical research terms, familiarity with data capture systems, and knowledge of software testing and validation. Time management and organizational skills will be needed to keep track of multiple tasks. Excellent communications skills, including the ability to explain and defend required procedures and processes to a variety of audiences with varying familiarities with technical jargon are critical. Independent decision making and problem-solving abilities are essential.

We are seeking an individual who is collaborative, communicative, solution-oriented and organized, proactive, able to think critically, focused on quality, passionate about research, dedicated to personal growth, and highly motivated to bring properly-resourced clinical trials to our patient community.

Key Responsibilities:

The primary function of this position is to develop, test, release, and maintain electronic case report forms (eCRFs) within electronic data capture systems (EDCs) for CU faculty investigator-initiated and grant-funded clinical trials, and to facilitate data management of project EDC builds.

Other important responsibilities include collaborating with other stakeholders to develop procedures and strategies to implement the Advarra EDC system on campus and within CReST.

Electronic Case Report Form (eCRF) development (40%)

• Independently, and under the oversight of CReST leadership, develop, test, release, and maintain eCRFs, EDC calendars, and other tools for data capture, in compliance with established SOPs and 21 CFR Part 11 regulations, as applicable.

• Design and program study electronic case report forms (eCRFs) with consideration of Quality by Design best practices.

• Review clinical study documents (e.g., protocol, study plans) and meet with study investigators and teams to identify forms and fields needed for each study.

• Make initial and subsequent revisions to database forms based on feedback from PI, monitors, statistician, and clinical team as needed (revisions may be identified during monitoring visits, protocol amendments, etc.).

• Write eCRF Completion Guidelines.

• Train study site staff on data entry procedures.

• Develop and validate standardized form templates for adaptation to specific protocols.

Data Management (30%)

• Write and deploy study-specific Data Management Plans, including procedures for database validation, periodic performance and data checks, access roles and responsibilities, testing, release, and management of eCRFs, and final data delivery parameters.

• Define and create automatic queries/alerts to ensure quality of data entered into the EDC

• Define procedures for periodic checks of the functionality of the database and the validity/completeness of the entered data, and maintain records of checks performed.

• Create and run reports as needed for data review by other entities (e.g., medical directors, etc.).

• Provide data and analytics related to monitoring trends to the Monitoring team and stakeholders.

• Manage database lock review, tasks, and timelines to ensure on-time deliverables.

Process and Procedure Development and Improvement (10%)

• Collaborate and build relationships with key stakeholders to develop and revise SOPs and implementation strategies for Advarra EDC on campus.

• Maintain and utilize up-to-date knowledge of relevant regulations (e.g. 21 CFR Part 11), guidelines, standards, and policies, serving as a subject matter expert on their applicability to EDC/eCRF development and data management.

• Proactively identify applicable tests, clinical procedures, and practices that commonly apply to protocol and EDC implementation, and maintain a working knowledge of the necessary information.

• Explain and defend best practices and required procedures and processes to a variety of audiences with varying familiarities with technical jargon in a professional manner.

Customer Service (10%)

• Facilitate help requests related to Advarra EDC.

• Relay timely information and project updates to PI’s, study staff, CReST leadership, and other key stakeholders, and respond to requests for updates or information quickly.

• Respond to and address study team questions and requests for help and/or changes to released versions of eCRFs as defined in the Clinical Monitoring Plan.

• Develop budget estimates for EDC builds using established templates for potential customers.

General (10%)

• Effectively communicate all EDC updates to the Monitoring team in a timely manner.

• Accurately track billable time dedicated to EDC/eCRF build and data management duties, aligning with team targets and expectations.

• Exhibit professionalism and accountability by aligning with the CReST Team Expectations.

• Engage with teammates and support a collaborative, congenial team culture.

Other duties may include:

• Assisting CReST managers and leadership in metric, tool, and process development in support of continuous quality improvement within the department.

• If needed and as assigned by the manager, may assist with regulatory submissions or other tasks for CReST-facilitated human subjects research projects.

• Performing other duties as assigned by the manager.

Work Location:

Hybrid – this role is eligible for a hybrid schedule of 4 days per week on campus and as needed for in-person meetings.

Why Join Us:

The full-time CReST Central Data Monitor will be a key member of the Clinical Research Support Team (CReST). CReST is part of the Office of Clinical Research Operations Support (CROS) in the Office of the Vice Chancellor for Research (OVCR). CReST provides support to investigators for all activities related to the successful conduct of clinical research, from study start-up through close out, under a fee for service model.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options

• Dental: Multiple plan options

• Additional Insurance: Disability, Life, Vision

• Retirement 401(a) Plan: Employer contributes 10% of your gross pay

• Paid Time Off: Accruals over the year