Clinical Research Regulatory Specialist

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 Clinical Research Regulatory Specialist is responsible for the management of clinical 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 regulatory guidance and direction to all members of the research team at Children's Hospital Colorado to ensure compliance with all applicable policies, procedures and regulations.

This position will be within the centralized research infrastructure at Children's Hospital Colorado, within the Research Institute. This position will support both industry and non-industry sponsored research within the Section of Neurology.

Department: CCHRI - Operations
Hours per week: 40, eligible for benefits
Shift: Monday - Friday, 8am to 4:30pm. Work hours may vary due to department needs.

*This is a hybrid position.

• Education: Bachelor's degree in a related field is required.
• Experience: Minimum of three (3) years of related experience is required.
• Equivalency: Minimum of seven (7) years of related experience may be considered in lieu of minimum requirements.
• At least two (2) years of direct regulatory experience is preferred.

• 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.

• Independently develops and submits Study Institutional Review Board (IRB) documents such as consent forms and protocols for initial submissions, protocol amendments, and continuing reviews.
• Independently maintains appropriate study documentation including regulatory binders and enrollment logs.
• 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 Standard Operating Procedures (SOPs) as needed.
• Submits Adverse Event Reports and Protocol Deviations according to institutional review board and sponsor-specific reporting requirements.
• Assesses current departmental processes and SOPs; provides suggestions for improvement.
• Enters protocol specific data into required IRB and Children's Hospital Colorado systems.
• Assists research team members in assessing and optimizing departmental workflows.
• Assists in training/mentoring new staff, providing constructive feedback to other team members as necessary.
• 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.
• Maintains study compliance with Institutional Review Board, CHCO and other policies.
• Oversees the maintenance and delegation of authority logs and documentation of training of key personnel on assigned studies.
• Communicates clearly and in a professional manner with study teams, sponsors and IRB including timely communication when revisions or changes have been approved.
• Recognizes when others need to be included in conversations and escalates appropriately.
• Works closely with sponsors and study teams on the preparation of regulatory documents and addressing relevant regulatory issues.
• Regularly participates in departmental meetings to discuss the regulatory status of assigned protocols.

SCOPE & LEVEL

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

Complexity: Duties and tasks are varied and somewhat complex, but usually involve limited responsibility. Procedures, methods and techniques to carry out work may not be well defined, requiring greater analysis.

Decision Making: Has some discretion in making some 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 own function with team members, peers, management, clients and in limited cases, the public. Uses some discretion and independent judgment when information is exchanged, gathered and/or presented. Defers to higher level team members and/or management in many situations.

Supervision Received: Works under some supervision, conferring with higher level employees, supervisor and/or manager as needed.

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.

The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of attendance at or graduation from an educational institution. You will not be penalized for redacting or removing this 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.