The University of Texas Medical Branch Regulatory Associate - OBGYN - Perinatal Research Division in Galveston, Texas
Bachelor’s degree or equivalent and two years of related experience.
Coordinates the daily activities associated with the processing of minimal risk research protocols and all facets of protocol review management to assist the Institutional Review Board. Additionally provides review, and analysis regarding changes to approved research protocols, adverse events and protocol deviations.
Commensurate with experience.
This position is in the pay band code: SC23.
Specific Job Related Duties
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.
Oversees all aspects of regulatory compliance as it pertains to the essential components of a clinical trial including submissions to IRB, FDA, NIH, and internal ancillary committees patient informed consent form, and other required regulatory documentation;
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 including FDA, IRB, NIH, and other internal ancillary committees;
Ensures accurate reflection of the budget in regulatory documents indicated for all study related and standard of care billing;
Monitors enrollment goals and initiates recommendations for increase or decrease of target patient enrollment goals to maintain regulatory compliance.
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.
Independently recognizes, tracks and reports increased risks to participants on clinical studies.
Prepares for and participates in audits made by sponsors or federal agencies during course and at the close of the study.
Prepares, submits and maintains IRB, FDA, NCI, NIH, and/or other regulatory documents and research correspondence for all investigator-initiated, cooperative group and industry sponsored clinical studies.
Coordinates with investigator or study sponsor to ensure all regulatory activities are appropriately maintained and completed.
Recommends and implements changes in process and policy issues and provides guidance on meeting regulatory requirements.
Contributes to developing educational materials on regulatory processes and requirements for the community and other research professionals regarding studies and related research issues.
Supervises, mentors and trains new or junior research staff.
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).
Develops and maintains regulatory databases to ensure appropriate regulatory procedures are tracked and monitored.
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.
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 and are considered mandatory for hire.
Two years clinical trials/research experience or equivalency required; Bachelor’s degree in a research or related area a plus. Demonstrated human relations and effective communication skills also required.
One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred.
Equal Employment Opportunity UTMB Health strives to provide equal opportunity employment without regard to race, color, national origin, sex, age, religion, disability, sexual orientation, gender identity or expression, genetic information or veteran status. As a VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities.
Full/Part Time: Full-Time
Job Type: Regular
Job Title: Regulatory Associate - OBGYN - Perinatal Research Division
Job ID: 60489
Business Unit: SOMED