Location
Office-based in Irving, TX
Job Summary
The Regulatory Affairs Coordinator will act as liaison between NEXT Oncology, the Institutional Review Board, and various Pharmaceutical and Biotech companies (Sponsors) to open clinical trials at NEXT Oncology.
Essential Duties and Responsibilities
Essential and other important responsibilities and duties may include but are not limited to the following:
Draft new informed consent forms for new studies and revise current informed consent forms as required due to updated study documents.
Submit new studies to the Institutional Review Board (IRB) for approval.
Submit changes to the protocol, informed consent forms, investigator’s brochures, drug diaries, etc. to the IRB.
Work with the Research Coordinators to ensure that all patient facing material, included but not limited to, informed consent forms, are available in all languages required for potential and current patients.
Submit any reportable events to the IRB, including serious adverse event reports, safety reports (i.e., SUSARs or similar reports), and protocol deviations.
Ensure studies are kept open at the IRB by submitting continuing review reports on time.
Submit closure notifications to the IRB as necessary when applicable.
Distribute new or updated study documents to appropriate staff when received and provide submission status of the items.
Enter study-specific information (such as but not limited to, study title, assigned staff, documents received from Sponsor, IRB submission/approval dates, etc.) in internal FileMaker database to provide a complete history of each clinical trial.
Complete various documents (such as but not limited to: Form FDA 1572s, Protocol Signature pages, IB Acknowledgement of Receipts, etc.) for clinical studies being conducted at NEXT Oncology.
Maintain current certifications and ranges for all laboratories being used in the conduct of clinical trials at NEXT Oncology.
Receive incoming correspondence/files and review/forward to appropriate staff.
Attend Phase I meetings, Site Initiation Visit meetings, and other meetings as applicable.
Provide coverage for Regulatory Affairs Assistants, as needed.
Perform a variety of administrative duties including but not limited to: answering phones; faxing and filing of confidential documents; and basic Internet and email utilization.
Provide excellent customer service to all internal and external customers.
Knowledge, Skills and Abilities
Proficiency in Microsoft Word and Adobe Acrobat
Excellent verbal and written communication skills
Required Education and Experience
Bachelor’s degree in administration or science
At least three-year experience in Regulatory Affairs in a research setting
Why Join Us?
At NEXT Oncology (an Avacare Business), you’ll be part of a mission-driven team that values collaboration, precision, and patient safety. Our team is known for its supportive culture, strong communication, and commitment to excellence in clinical research.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $46,200.00 - $96,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.