*SUMMARY*
Ideal candidate has successful prior experience with Clinical Research Regulatory preparation.
This position provides specialized administrative support in a clinical research environment for the development of regulatory documentation for clinical research projects.
This position also provides clinical research coordinator support, as needed, to a variety of clinical research projects.
Functions as compliance/oversight by monitoring overall study compliance with GCP and protocol.
*ESSENTIAL DUTIES AND RESPONSIBILITIES:*
*Primary Duties include:*
· Review protocols to abstract pertinent information.
· Work with Sponsor and PI/study staff to develop and submit IRB and R&D regulatory packets.
· Ensure required internal services are available for the successful conduct of study requirements.
· Assist with and coordinates the development of protocols, submission to regulatory and/or funding agencies and follow-up of the approval process.
· Assist in in-progress and end-of-study review activities as called for by regulatory and/or funding agencies.
· Act as liaison between investigator and sponsor.
· Informs research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments.
· Responsible for the creation and revisions to informed consent and HIPAA forms.
· Responsible for maintaining essential regulatory documents including FDFs, 1572s, DOA logs, and other study-related documentation.
· Prepares for and may participate in sponsor monitoring visits and audits.
· Attends applicable meetings including, but not limited to disease group meetings, SIVs, IMVs, and COVs.
*Secondary Duties Include:*
· Assist with informed consent process (or serve as witness to informed consent process) and explain study to participants in easily understandable plain terms.
· With direction from lead coordinator, Communicate study data and results to investigator and sponsor.
· Maintain complete source documentation and prepare study activity reports for sponsors, regulatory bodies and other entities as necessary and appropriate.
· Facilitate payment procedures to trial participants.
· Respond to audit requests from compliance and other related entities.
· Conduct QA/QC reviews to provide internal audit feedback to coordinators/study staff
· Perform general administrative duties in support of the study(ies).
· May support studies at both VA and UTHealthSA locations.
· Other duties as assigned.
Due to our close relationship with the VA, this position requires a VA (federal) appointment and submission to a full federal background check.
The VA approval process averages 4 months and employment cannot begin until the VA vetting process has been completed.
Candidates will be selected soon, but employment and onboarding will be delayed until the VA appointment has been received.
Job Type: Full-time
Benefits:
* Dental insurance
* Employee assistance program
* Flexible spending account
* Health insurance
* Health savings account
* Life insurance
* Paid time off
* Professional development assistance
* Retirement plan
* Vision insurance
Schedule:
* 8 hour shift
* Monday to Friday
Application Question(s):
* Are you willing to submit to fingerprinting and a federal background check?
Experience:
* Clinical Research regulatory: 1 year (Preferred)
Work Location: In person
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