Clinical Research Regulatory Specialist

SUMMARY

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.

Additional Information:

Department: CCHRI-CCBD Clinical
Hours: 40 hours/week
Shift: Shift = M-F, 8am - 4:30pm (hybrid work available)

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 Standard Operating Procedures (SOPs) as needed.
4. Submits Adverse Event Reports and Protocol Deviations according to institutional review board and sponsor-specific reporting requirements.
5. Assesses current departmental processes and SOPs; provides suggestions for improvement.
6. Enters protocol specific data into required IRB and Children's Hospital Colorado systems.
7. Assists research team members in assessing and optimizing departmental workflows.
8. Assists in training/mentoring new staff, providing constructive feedback to other team members as necessary.
9. 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.
10. Maintains study compliance with Institutional Review Board, CHCO and other policies.
11. Oversees the maintenance and delegation of authority logs and documentation of training of key personnel on assigned studies.
12. Communicates clearly and in a professional manner with study teams, sponsors and IRB including timely communication when revisions or changes have been approved.
13. Recognizes when others need to be included in conversations and escalates appropriately.
14. Works closely with sponsors and study teams on the preparation of regulatory documents and addressing relevant regulatory issues.
15. Regularly participates in departmental meetings to discuss the regulatory status of assigned protocols.
    

MINIMUM QUALIFICATIONS

• 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.

Direct regulatory experience preferred

Salary Information
Pay is dependent on applicant's relevant experience.

Annual Salary Range (Based on 40 hours worked per week): $66,083.89 to $99,125.84

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.

EEO Statement
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.