Children’s Hospital Colorado Hiring for Senior Clinical Research Regulatory Specialist CCBD at Aurora, CO  Full Time

Here, it’s different. Come join us.

Children’s Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years.

Here, the nation’s brightest nurses, physicians, scientists, researchers, therapists, and care providers are creating the future of child health. With an optimist’s outlook, a trailblazing spirit, and a celebrated history, we’re making new strides every day.

We’ve been Magnet-designated four times by the American Nurses Credentialing Center and are consistently recognized among the best of the best pediatric hospitals with #1 rankings in Colorado and the region by U.S. News & World Report.

As a national leader in pediatric care, we serve children and families from all over the nation. Our System of Care includes four pediatric hospitals, 11 specialty care centers, 1,300+ outreach clinics and more than 10,000 healthcare professionals representing the full spectrum of pediatric care specialties.

Here, we know it takes all of us, every role, to deliver the best possible care to each child and family we treat.

That’s why we build our teams toward a foundation of equity in access, advancement, and opportunity. We know teams of individuals with different identities and backgrounds can nurture creativity and innovation. We know we can see, treat, and heal children better when our team reflects the diversity of our patient population. We strive to attract and retain diverse talent because we know a truly inclusive and equitable workforce will help us one day realize our most basic calling: to heal every child who comes through our doors.

A career at Children’s Colorado will challenge you, inspire you, and motivate you to make a difference in the life of a child. Here, it’s different.

The Senior Clinical Research Regulatory Specialist is responsible for the management of complex research protocol documents and activity from initial submission through study closure. The primary focus is on the development, submission, maintenance, filing and reporting of regulatory documents while achieving and maintaining compliance with all internal, external and federal policies and regulations that apply to research involving human subjects. Provides advanced regulatory guidance and direction of complex matters to all members, including to less experienced Regulatory Specialists, of the research team at Children’s Hospital Colorado to ensure compliance with all applicable policies, procedures and regulations.

This position will support the Neuro-Oncology and Surge clinical trial programs. This program participates in industry, numerous IIT and compassionate use studies from pilot and feasibility studies up through phase III. The team member in this position is key to supporting the clinical trials (compliance, startup of studies, amendments, continuing reviews, etc.) in addition to performing other job essential functions of the regulatory specialist. The successful applicant will have a strong background as a regulatory specialist that compliments the needs of the Neuro-Oncology & Surge teams.

Department: RI-CCBD Clinical Research
Hours per week: 40, eligible for benefits
Shift: Monday – Friday, 8am to 4:30pm. Work hours may vary due to department needs. This position may have the possibility of being hybrid upon successful completion of department on-boarding/training and job performance.

Education: Bachelor’s degree in a related field is required.
Experience: Minimum of five (5) years of related experience is required.
Equivalency: Minimum of nine (9) years of related experience may be considered in lieu of minimum requirements.

POPULATION SPECIFIC CARE

No direct patient care.

ESSENTIAL FUNCTIONS
An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions which the employee may be expected to perform.

1. Independently develops and submits Study Institutional Review Board (IRB) documents such as consent forms and protocols for initial submissions, protocol amendments, and continuing reviews.
2. Independently maintains appropriate study documentation including regulatory binders and enrollment logs.
3. Responsible for preparing, maintaining and updating regulatory binders for review by internal or external monitoring/auditing groups; available to auditors and monitors to discuss regulatory issues at each visit; able to explain internal regulatory processes and SOPs as needed.
4. Submits Adverse Event Reports and Protocol Deviations according to institutional review board and sponsor-specific reporting requirements. Serves as a subject matter expert on reporting requirements.
5. Works closely with investigators in the preparation and submission of Investigational New Drug (IND) applications to the U.S. Food & Drug Administration (FDA).
6. Serves as a departmental subject matter expert for guidance on IRB communications and related regulatory matters.
7. Contributes to department wide training on research regulatory requirements.
8. Leads the development, improvement and implementation of departmental standard operating procedures and study specific processes. Evaluates team members’ suggestions to improve processes and Standard Operating Procedures (SOPs).
9. Enters protocol specific data into required IRB and Children’s Hospital Colorado systems.
10. Assists research team members in assessing and optimizing departmental workflows.
11. Serves as an expert for training/mentoring other team members, providing constructive feedback as necessary.
12. Maintains understanding of the professional guidelines and code of ethics related to clinical research conduct, and maintains ability to summarize and clarify these for study teams.
13. Maintains study compliance with IRB, CHCO and other policies.
14. Oversees the maintenance and delegation of authority logs and documentation of training of key personnel on assigned studies.
15. Communicates clearly and in a professional manner with study teams, sponsors and IRB including timely communication when revisions or changes have been approved.
16. Recognizes when others need to be included in conversations and escalates appropriately.
17. Works closely with sponsors and study teams on the preparation of regulatory documents and addressing relevant regulatory issues.
18. Acts as an expert regulatory resource for other team members and principle investigators.
19. Regularly participates in and/or leads departmental meetings to discuss the regulatory status of assigned protocols.

SCOPE & LEVEL

Guidelines: Possesses and applies a broad knowledge of concepts, practices and procedures within a particular field of specialization.

Complexity: Duties and tasks are broad and complex, usually requiring a greater degree of responsibility. Procedures, methods and techniques to carry out work may not be well defined, requiring advanced knowledge in specific specialties and of the organization.

Decision Making: Has latitude in making most decisions. Decisions and recommendations are made after contemplative analysis and with independent judgment and ingenuity. May escalate the most complex and important decisions to a higher level employee, supervisor and/or manager.

Communication: Communicates explanatory and/or interpretive information relative to the organization and/or advanced knowledge of own function with team members, peers, management, clients and in some cases, the public. Uses discretion and independent judgment when information is exchanged, gathered, defended and/or presented. Defers to higher level team members and/or management only when necessary.

Supervision Received: Works under limited supervision and with a high degree of independence, conferring with supervisor and/or manager on unusual matters. May be assisted by lower level employees.

PHYSICAL REQUIREMENTS
Vision – Near: Clear vision at 20 inches or less
Weight Lifted/Force Exerted: up to 10 pounds/4.5 kilos, up to 1/3 of time
Hearing: Able to clearly hear details
Sit: 2/3 or more of time
Talk: Able to communicate verbally
Mental/Emotional: Able to work in close proximity to others and/or in a distracting environment
Mental/Emotional: Able to cope with stress effectively
Mental/Emotional: Able to prioritize effectively

WORK ENVIRONMENT
Mental/Emotional: Able to tolerate ambiguity
Mental/Emotional: Able to prioritize effectively
Mental/Emotional: May be subject to many interruptions
Office Work Environment: Regular/frequent exposure
Bloodborne Pathogen Category 2: Occasional exposure to blood/body fluid

It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information.

Salary Information

Annual Salary Range (Based on 40 hours worked per week): $74,870.78 to $112,306.17
Hourly Salary Range: $36.00 to $53.99

Benefits Information

Here, you matter. As a Children’s Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.

As part of our Total Rewards package, Children’s Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.

Children’s Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.