Posted in Other 30+ days ago.
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Type: Full Time
Bachelor s degree and five years of demonstrated success and experience in related or equivalent field and effective written communication skills. Outstanding documentation and attention detail. Must possess excellent interpersonal skills as well as effective verbal and written communication skills. Must possess leadership skills and have the ability to relate to a diverse group. Must demonstrate initiative, diplomacy, tact and professional demeanor.
JOB DESCRIPTION :
Provides regulatory expertise to faculty members, principal investigators and research personnel in order to comply with federal regulations related to research involving human subjects. Drives improvements to systems and procedures, acting as a proactive advocate of streamlining processes. Assists in the development, implementation and maintenance of policies and the delivery of timely service to customers.
Commensurate with experience
SPECIFIC JOB RELATED DUTIES
Develops, coordinates and oversees the submission process of regulatory documents to ensure compliance with governing requirements. Specifically, oversees submission and management of IND/IDE filings and Clinicaltrials.gov registration and results reportingDevelops, coordinates and oversees the submission process of regulatory documents to ensure compliance with governing requirements. Specifically, oversees submission and management of IND/IDE filings and Clinicaltrials.gov registration and results reporting
ESSENTIAL JOB FUNCTIONS:
* Supports all aspects of regulatory compliance.
* Servces as a resource for research staff institution wide on regulatory matters.
* Provides guidance in the development of consent forms and protocols as part of IND/IDE regulatory packet.
* Communicates with research committees, administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
* Tracks study approvals, reporting requirements and closeout processes to ensure uninterrupted project oversight.
* Submits amended protocols and consent forms to FDA.
* Ensures all reporting requirements of IND/IDE are met.
* Develops and delivers training pertaining to ClinicalTrials.gov registration and reporting.
* Oversees trial statuses on ClinicalTrials.gov website to ensure ongoing compliance.
* Proactively communicates upcoming required actions to the investigator to maintain compliance with all applicable ClinicalTrials.gov regulations and policies.
* Notifies investigator of ClinicalTrials.gov Problem Records requiring action.
* Communicates and refers ongoing, non-compliant investigators to Institutional Research Compliance according to institutional policy.
* Recommends and implements regulatory process improvements.
* Maintains high level of knowledge on legal and ethical issues related to human subject's research
* Serves as subject matter expert on ClinicalTrials.gov.
* Keeps abreast of changes in federal, state and local laws and guidelines pertaining to regulations governing human subject's research and disseminates relevant information to applicable staff.
* Supports regulatory aspects of multi-site investigator trials
* Generates ad hoc reports as requested
MARGINAL OR PERIODIC JOB FUNCTIONS:
* Performs related duties as required.
REQUIRED EDUCATION / EXPERIENCE:
Bachelor's degree or equivalent and five years of experience with clinical trials or clinical research experience, IND and/or IDE applications and effective written communication skills required.
Two years of experience in registration and results reporting in ClinicalTrials.gov.
Standard office equipment.
WORKING ENVIRONMENT/LOCATION OF POSITION:
Standard hospital, clinical laboratory and/or office environments.
Specific job requirements or physical location of some positions allocated to this classification, may render this position security sensitive, and thereby subject to the provisions of Section 51.215, Texas Education Code.
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.
Req id: 66833