University of Utah Regulatory Coordinator in Salt Lake City, Utah
Open Date 05/04/2018
Requisition Number PRN17110B
Job Title Regulatory Coordinator
Working Title Regulatory Coordinator
Job Grade E
FLSA Code Administrative
Patient Sensitive Job Code? No
Standard Hours per Week 40
Full Time or Part Time? Full Time
Work Schedule Summary
VP Area President
Department 01167 - HCI Clinical Trials Operations
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 39300 to 56000
Open Until Filled Yes
Regulatory coordination is a specialized function within clinical trials operations responsible for all regulatory processes across multiple studies in compliance with local and federal regulations, Standard Operating Procedures (SOP’s), and study-specific protocols.
Applicants must demonstrate the potential ability to perform essential job functions.
1.Oversees all aspects of regulatory compliance as it pertains to the essential components of a clinical trial including submissions toIRB,FDA,NIH, and internal ancillary committees patient informed consent form, and other required regulatory documentation;
2.Manages quality control, completion and submission of study related documentation related to new study applications, study amendments and continuing reviews, study report forms and requirements for registrations to regulatory authorities includingFDA,IRB,NIH, and other internal ancillary committees;
3.Ensures accurate reflection of the budget in regulatory documents indicated for all study related and standard of care billing;
4.Monitors enrollment goals and initiates recommendations for increase or decrease of target patient enrollment goals to maintain regulatory compliance.
5.Coordinates and performs responsibilities related to research participants including developing informed consents overseeing appropriate approval of all patient related materials by appropriate regulatory review committees.
6.Independently recognizes, tracks and reports increased risks to participants on clinical studies.
7.Prepares for and participates in audits made by sponsors or federal agencies during course and at the close of the study.
8.Prepares, submits and maintainsIRB,FDA,NCI,NIH, and/or other regulatory documents and research correspondence for all investigator-initiated, cooperative group and industry sponsored clinical studies.
9.Coordinates with investigator or study sponsor to ensure all regulatory activities are appropriately maintained and completed.
10.Recommends and implements changes in process and policy issues and provides guidance on meeting regulatory requirements.
11.Contributes to developing educational materials on regulatory processes and requirements for the community and other research professionals regarding studies and related research issues.
12.Supervises, mentors and trains new or junior research staff.
13.Coordinates with physicians to provide information on available or competing research protocols and assist in their development and submission of investigator initiated clinical studies to appropriate regulatory review committees (CCIC,IRB,FDA).
14.Develops and maintains regulatory databases to ensure appropriate regulatory procedures are tracked and monitored.
Bachelor’s degree in a research or related area plus two years clinical trials/research experience or equivalency required; demonstrated human relations and effective communication skills also required.
One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred.
This position is not responsible for providing patient care.
Department employees are expected to complete theIRBHuman Subjects Research course (Collaborative Institutional Training Initiative –CITI) within the first week of hire and the UniversityRATSClinical Certification within the first year of hire, SoCRA orACRPcertification favored. Employees with SoCRA orACRPcertification are expected to complete continuing education and maintain active membership. Applicants should have knowledge of Good Clinical Practices,FDA,HIPAAandIRBregulations as well as the ability to read, interpret, understand, and implement written guidance from various regulatory bodies.
Incumbent will be expected to work collaboratively within the department and the regulatory team but should also have the capacity and desire to operate independently and to self-motivate. Time management and task prioritization are imperative functions of the position.
Exceptional organizational capacity, high attention to detail, and outstanding communication skills are critical to the position. This position is not responsible for providing patient care.
The incumbent decides how to best accomplish the daily requirements of various protocol regulatory requirements, prioritizes and delegates workload and establishes systems needed to achieve specific regulatory goals. Efforts of multiple departments or disciplines be coordinated to ensure effective follow through and compliance of all involved.
The incumbent is expected to closely monitor studies in which experimental equipment and drugs are utilized. Federal regulations mandate the regulatory requirements for use of investigational new drugs or devices and the subjects participating in research studies often have no other option for recovery. Analysis on critical research studies is strongly preferred in order to maintain accurate regulatory record compliance with all aspect of the research study in accordance with federal regulations.
The incumbent utilizes federal and institutional guidelines and requirements to inform and complete submission of regulatory activities. This position negotiates and communicates extensively with University research protection committees and sponsors to ensure full compliance.
The incumbent is responsible to organize coverage when not present to ensure regulatory requirements are followed.
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Type Benefited Staff
Special Instructions Summary
The University of Utah is an Affirmative Action/Equal Opportunity employer and is committed to diversity in its workforce. In compliance with applicable federal and state laws, University of Utah policy of equal employment opportunity prohibits discrimination on the basis of race or ethnicity, religion, color, national origin, sex, age, sexual orientation, gender identity/expression, veteran’s status, status as a qualified person with a disability, or genetic information. Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities, and protected veterans are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.
To inquire about this posting, email: firstname.lastname@example.org or call 801-581-2300. Reasonable accommodations in the application process will be provided to qualified individuals with disabilities. To request an accommodation or for further information about University AA/EO policies, please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/ TDD ), email: email@example.com .
The University is a participating employer with Utah Retirement Systems (“URS”). To be eligible for retirement contributions, you must be hired into a benefit-eligible position. Certain new hires are automatically assigned to the URS retirement plan and other employees with prior URS service, may elect to enroll in the URS within 30 days of hire. Regardless of whether they are hired into a benefit-eligible position or not, individuals who previously retired and are receiving monthly retirement benefits from URS must notify the Benefits Department upon hire. Please contact Utah Retirement Systems at (801)366-7770 or (800)695-4877 or the University’s Benefits Department at (801)581-7447 for information.
This position may require the successful completion of a criminal background check and/or drug screen.