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 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. 

The ideal candidate will have familiarity with clinical research terms, familiarity with data capture systems and some 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.

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 - 30%

• 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.

Collaboration and Leadership - 5-10%

• Lead the on-campus EDC roundtables, collaborating with and triaging information to key on-campus stakeholders.
• 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- 15%

• Serve as the primary contact to triage 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 – 15%

• 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: 0-15%

• 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:

Remote– this role is eligible to work 100% remotely, but the employee must be in the United States. Preference will be given to candidates in the Colorado area who can come to campus for several days during initial training, and potentially

1x/month to 1x/quarter, or as needed for on campus meetings and events.

Why Join Us:

Jobs in this career family provide direct professional support of research activities.  Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.

Senior Professionals are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying and sharing knowledge directly related to a professional field.  Work is performed fully independently.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness .

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

• A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution and 2 years of professional level experience as a clinical research coordinator, clinical research data coordinator, or similar role. 
• Experience in interventional clinical trials. 
• Oncology research experience.
• Experience programming and/or designing EDC databases, medical coding dictionaries, and quality control processes. 

Applicants must meet minimum qualifications at the time of hire.

Substitutions

• A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.

Preferred Qualifications:

• 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.
• Experience working in an academic setting.
• Health data certification or experience in biostatistics
• Technical or procedure writing experience.
• Familiarity with Industry-standards regarding clinical research data methodologies

Knowledge, Skills and Abilities:

• 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.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• 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.

How to Apply:

For full consideration, please submit the following document(s):

1.     A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2.     Curriculum vitae / Resume

3.     Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Erin McDonagh; [email protected]

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by April 2, 2024.

Anticipated Pay Range:

The starting salary range (or hiring range ) for this position has been established as $56,169 - $71,447.

The above salary range (or hiring range ) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator: http://www.cu.edu/node/153125

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at [email protected] ​.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program .