Regulatory Specialist
Regulatory Specialist
Posted on :
08-06-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
08-06-2025
Job Description
The primary focus of theRegulatory Specialistis to organize regulatory information and track and control submissions for the clinical pharmaceutical and device protocols conducted at AICR while following applicable federal regulations/ICH guidelines medical ethics HIPAA rules GCP IRB requirements AICRs SOPs and sponsor/Contract Research Organization (CRO) protocol requirements.
JOB DUTIES:
Tasks may include but are not limited to:
- Collect and coordinate information and prepare regulatory documentation for submission to IRBs.
- Compiles materials for license renewals updates and registrations in a timely manner.
- Track and control submissions to IRB (Investigational Review Board).
- Review and advise on labeling for compliance with regulatory filings.
- Research regulatory issues and provide guidance and advice to colleagues.
- Maintains regulatory binders for all studies accurately.
- Meets with Monitor during monitoring visits to review the Regulatory Binder.
- Responds to Monitor notes and/or emails in a timely manner.
- Is creative and diligent in the recruitment of qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsors timeline while following all policies and regulations governing medical ethics IRB requirements federal regulations/ICH guidelines GCPs and AICRs SOPs.
- Complies with all HIPAA regulations.
- Maintains ongoing communication with Director of Research Principal Investigator/Sub-Investigator other study personnel and sponsor/CRO per AICR SOPs and as deemed necessary
- Possesses a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed by monitors or other staff members.
- Must attend Investigator Meetings as directed.
- Promptly reports adverse events to Associate Director of Research Principal Investigator/Sub-Investigator sponsor/CRO as deemed necessary and to ensure subject safety.
- Reports Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also reports the SAE to Associate Director of Research and/or Principal Investigator/Sub-Investigator.
- Maintains confidentiality of patient and/or protocol issues as appropriate and as bound by Confidentiality Agreements with AICR between AICR and sponsors and between AICR and other entities.
- Represents AICR in a professional and courteous manner (verbal written and in appearance) when interacting with AICR staff sponsors IRBs and subjects.
- Travel required.
- Other duties as assigned
POSITION QUALIFICATIONS:
- High school diploma with three (3) years of relevant experience or Associates degree with two (2) years of relevant experience BS/MS degree may substitute for relevant experience.
- Experience in the field of clinical research is preferred.
- Proficient with Microsoft office suite and Adobe.
- Experience with Clinical Trial Management System (CTMS) preferably RealTime.
- Must attend required training courses/conferences in order to stay abreast of current and changing federal regulations and AICR policies.
- Actively pursues educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.
- May require infrequent night and early mornings and/or weekend work.
- Ability to drive and daily availability of an automobile
- Must be moral and ethical in decision-making and during interaction with patients sponsor and IRB representatives physicians and other staff.
- Able to independently manage work flow.
- Must be an excellent multi-tasker with the ability to prioritize work.
- Meticulous attention to detail and strong organizational skills
Come see what its like to have an amazing employee experience with one of the best teams in the Research world.
PERKS OF JOINING OUR TEAM!
PERKS OF JOINING OUR TEAM!
- We valueIntegrity Teamwork Compassion Innovation&Excellence
- Competitive Salary
- Great Healthcare Plan for you and all dependents (we help you out with the cost!)
- Voluntary Dental Vision STD Accident LTD and Life
- Retirement contribution with Company match
- Company provided life insurance
- Paid Time off (PTO)
- Paid holidays
- Company sponsored events
- Employee rewards and recognition programs
- An environment in which you can balance great work with a great life
Austin Institute for Clinical Research is an Equal Opportunity Employer
Required Experience:
Unclear Seniority
Employment Type
Full Time
Key Skills
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