Clinical Sciences Manager - NORA

Job Summary:

Clinical Sciences Managers independently manage clinical research programs, perform clinical research project management functions, and supervise clinical research teams of 3 or more FTE. The Manager is responsible for the management, development, implementation and oversight of the clinical research operations and functions in the assigned unit. The manager also provides policy guidance and interpretation to the team and other stakeholders on a wide variety of personnel and operational issues assuring compliance with Federal, University, and departmental rules and regulations.

Neonatal Outcomes Research Alliance (NORA) is a collaborative of providers and clinical researchers in perinatal medicine within the Section of Neonatology.  The Clinical Research Manager will manage all phases of study design, implementation, and dissemination of research and quality improvement projects conducted by NORA investigators. As of February 2024, this includes 27 unique projects among 15 different PIs. The Clinical Research Manager will formally supervise a team of 3 research services professionals. The ideal candidate will have experience managing human subjects research projects, and strong interpersonal skills needed to work with various stakeholders involved in multisite quality improvement projects.

Key Responsibilities:

• Supervise 3 full-time research service professionals.
  • Responsible for oversight of daily tasks and work product.
  • Onboarding and ongoing training of employees.
  • Delegating and allocating work and responsibilities to program staff
  • Assuring research service professionals and their projects comply with Federal, University, and departmental rules and regulations.
  • Ongoing communication regarding job performance/progress and completion of annual performance evaluations.
  • Approval of leave requests in MyLeave.
  • Manage recruitment of future research professionals if/when needed.
• Develop program/project goals and communicate goals and outcomes with various stakeholders.
• Participate in tactical and strategic program/project development and planning.
• Manage program/project budget development processes, including grant writing and submission processes, and regularly review to ensure alignment.
• Manage program/project start-up and close-out functions.
• Liaise and coordinate with various program/project stakeholders, including, but not limited to, program/project sponsors, regulatory agents, pharmaceutical representatives, and clinic/hospital staff.
• Develop, review, and maintain regulatory and other program/project documentation.
• Ensure program/project compliance with the Food and Drug Administration (FDA) and other regulatory bodies.
• Coordinate site visits and other meetings with key stakeholders.
• Develop and maintain a variety of reports and communicate and present data to stakeholders.
• Develop and implement community outreach and engagement initiatives.
• Manage and oversee the day-to-day operations of clinical trials and studies for the NORA group.
• May perform duties and responsibilities of Clinic Research Professionals when necessary.
• Develop protocol-specific systems and documents, including process flows, training manuals, Standard Operating Procedures (SOPs), and Case Report Forms (CRFs). Maintains subject-level documentation and prepares documents, equipment, and/or supplies.

Additional Duties & Responsibilities:

• Manage statewide/regionwide multisite quality improvement collaboratives that include other hospital systems and non-profits.
• Coordinate various sub-projects that are taking place within the broader collaborative efforts.
• Conduct rigorous stakeholder and communication management tasks to recruit and maintain engagement of numerous projects partners at various sites.
• Manage submission process for Date Use Agreements (DUA) and Business Associate Agreements (BAA) to ensure regulatory compliance among all sites.
• Plan, facilitate, and document internal research team meetings and external steering and advisory committee meetings for the quality improvement collaboratives.
• Identify, track, mitigate, and resolve all project related issues.

This description is a summary only and describes the general level of work being performed; it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business needs. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Work Location:

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

Why Join Us:

The Section of Neonatology faculty are nationally and internationally recognized researchers with a broad range of research interests fostering programmatic areas of excellence.

Our Neonatology faculty have pioneered many critical developments in neonatal care for critically ill newborns and, in many cases, were the first in the world to use new therapies including:

• Surfactant replacement for premature babies’ lungs.
• Inhaled Nitric Oxide therapy for pulmonary hypertension.
• Brain cooling for perinatal brain injury.
• Optimal nutritional strategies for low-birth-weight babies.

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, 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:

• Bachelor’s degree in any field.
  • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year-for-year basis.
• Five (5) years of clinical research or related experience.

Condition of Employment:

• Must successfully pass a drug test through Children’s Hospital Colorado.
• Must be willing and able to pass a national criminal background check.

*For questions regarding Children’s Hospital drug testing requirements, please contact Children’s Human Resources at 720-777-8598. Some positions may require testing if access to Children’s Hospital or their systems is needed at any time during employment with the University. If drug testing is required, it will be listed in the job posting.

Preferred Qualifications:

• Master’s degree in Public Health, or related field.
• Prior experience providing program and/or project management duties in a clinical research setting.
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).

Knowledge, Skills, and Abilities:

• Strong project management skills and experience within a complex and diverse environment.
• Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
• Demonstration of strong analytical and problem-solving skills.
• 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.
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.

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

Applications are accepted electronically ONLY at www.cu.edu/cu-careers .

Questions should be directed to: Diane.Hitchcock, [email protected]

Screening of Applications Begins:

Immediately and continues until 5 days after the initial posting.

Anticipated Pay Range:

The starting salary range (or hiring range ) for this position has been established as $70,211 to $89,308.

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.

Perks & Benefits: https://advantage.cu.edu/search

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 .