Regulatory Affairs Coordinator

IQVIA • Fort Worth, TX

1d • Onsite

About The Position

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. This role involves drafting and revising informed consent forms, submitting new studies and changes to the Institutional Review Board (IRB), ensuring patient-facing materials are available in required languages, reporting adverse events, maintaining study status, distributing study documents, entering study information into a database, completing study-specific documents, maintaining laboratory certifications, receiving and forwarding correspondence, attending meetings, and providing administrative support. The position also requires excellent customer service skills.

Requirements

• Proficiency in Microsoft Word and Adobe Acrobat
• Excellent verbal and written communication skills
• Bachelor’s degree in administration or science
• At least three-year experience in Regulatory Affairs in a research setting

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level