Clinical Research Monitor I

Job Summary:

The full time Clinical Research Monitor I will be a key member of the Clinical Research Support Team (CReST). This position will focus on clinical monitoring and providing direct monitoring services for investigator-initiated studies, particularly those studies where the local researcher is the sponsor/IND holder. This position may also act in a clinical research coordinator role or help build case reports forms in an Electronic Data Capture (EDC) system to support the workload of the CReST team.

Key Responsibilities:

Clinical Research Monitoring: 70%

• Monitors data, regulatory, and protocol compliance through routine and for-cause or by request monitoring activities both in person and remotely.
• Develops risk-based monitoring plans based on the complexity of the study.
• Develops study-specific budgets for Clinical Monitoring and related services.
• Works with sites and investigators to schedule and conduct monitoring visits (Site Initiation, Interim, For-Cause/by request, and Close Out Visits)
• Develops training materials for Site Initiation Visits (SIVs) and documents protocol and GCP trainings.
• Develops visit agendas and follow up reports of visit findings. Disseminates reports to the study's principal investigator (PI) and other key stakeholders.
• Ensures quality of study data through source data verification and reconciliation.
• Assures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies.
• Under the direction of the CReST Program Director and as directed by senior monitoring staff, Collaborates to identify and take on monitoring projects and coverage within the Monitoring team.
• Assists with the development of eCRFs, EDC calendars or other appropriate database resources for data capture.

Communication: 20%

• Relays timely information to PI's, study staff, CReST leadership and other key stakeholders
• Collaborates with team members and external stakeholders, maintaining strong relationships and communication between groups.

Other: 10%

• Accurately tracks billable time in support of CReST program and financial goals.
• May provide regulatory support for clinical trials, including QA/QC reviews, submissions to institutional groups, IRBs and FDA on an as needed basis.
• If needed, may assist with clinical research coordination tasks for industry, federal or locally funded clinical studies.
• Other duties as assigned by manager

Work Location:

Onsite - this role is expected to work onsite and is located in Aurora, CO.

Why Join Us:

The Clinical Research Support Team (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
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 10/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

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, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. 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
• 2 years of professional level experience clinical research experience as a clinical research coordinator, clinical research data coordinator, or similar position
• Oncology research experience.
• ACRP, SOCRA, or RAC certification or the ability to attain this within 1 year of joining CReST

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

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Clinical Monitoring experience
• Experience working with investigator-initiated research.
• Three or more years of interventional clinical research experience, Including experience with Phase I/Phase II studies
• Epic or other EMR experience
• Experience drafting SOP and policy documents, especially those relating to clinical research monitoring activities
• Bi-lingual (Spanish & English)
• Technical writing experience

Knowledge, Skills and Abilities:

• Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
• Knowledge of Continuous Improvement practices
• Data management experience
• Ability to communicate effectively and with a high level of professionalism across various stakeholders
• Superior organizational skills
• Ability to work independently following training
• Ability to problem solve and prioritize tasks
• Possesses knowledge of Good Clinical Practices Manual, FDA Regulations 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.
• Demonstrated commitment and leadership ability to advance diversity and inclusion
• Familiarity with local and federal regulations and guidance

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: Molly Pomeroy, Molly.Pomeroy@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until the position is filled. For best consideration, apply by September 20, 2024.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $56,169 - $68,000

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 hr.adacoordinator@cuanschutz.edu.

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.