As the Regulatory Specialist, you will manage and track regulatory documents to maintain site compliance for industry sponsors, as well as maintain Good Clinical Practice (GCP) and Food and Drug Administration (FDA) requirements. In this role, you will work closely with site leadership, principal investigators, and staff as well as Sponsors, CROs and IRB staff. Your involvement starts from the time of study start-up, through the duration of the trial, and until study close.
The Regulatory Specialist MUST be a highly organized individual with exceptional multi-tasking and people skills, with the ability to maintain a strong working relationship with all internal departments, listeners, customers, and vendors. This is a VERY fast paced position with daily and sometimes hourly deadlines.
Duties Include, but are not limited to:
• Initiate IRB submission. Create and maintain regulatory documents.
• Daily check IRB portals for new consents, new approvals, distribute to team and file in trial specific binders.
• Tracking study start-up activities for multi-center clinical trials and providing regular updates to Project Directors, Sponsors and Leadership.
• Distribution, collection, processing and tracking of Essential Site Regulatory Documents for all ongoing clinical trials, including collection of updated Investigator CVs , licenses, GCP and human subjects training certificates. This process applies to both paper and electronic files for each study at the site.
• Acts as a liaison with sponsor, principal investigator, research manager, review committees.
• Monitors (internal & external) trial correspondence.
• File IND reports, emails, IRB approvals and correspondence.
• File IRB regulations annually.
• File IRB member roster quarterly.
• File all IP delivery correspondence.
• Perform annual IRB renewals, post initial submission.
• Monitors trends in regulatory/protocol processes and making recommendations for improvement.
• Provides guidance to ensure regulatory documents are filed and archived properly.
• Provides education, training and serving as a resource to improve research compliance.
• Track and file completion of ALL training, both protocol specific and general training as needed.
• Maintain & file CV’s, licenses, training and certifications of all physicians /investigators.
• Maintain/file lab manuals and site licenses (CLIA, etc.).
• File and maintain correspondence pertaining to ALL audits (sponsor, FDA).
Essential Skills and Experience:
• Knowledge of clinical research terminology and clinical regulatory standards.
• At least three years of clinical research experience, preferably with a site or site network
• At least two years of regulatory experience preferred, preferably with a site or site network.
• FDA, ICH-GCP experience, as well as IRB submission expertise.
• Able to work on multiple submissions across multiple IRB’s.
• High attention to detail and strong writing skills are essential.
• Organizational and follow-through skills are required.
• Individual must be able to successfully prioritize tasks and complete assignments under strict time deadlines.
• Proficiency in Microsoft Office (Word, Excel, Outlook) as well as CTMS system with eRegs/eDocs
· Bilingual is a plus!
Physical Requirements:
The physical requirements listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
· Prolonged periods of sitting at a desk
· Lift/move/carry up to 20 pounds
· Walking
· Standing
· Reaching
· Seeing
· Hearing
· Speaking
· Computer Use
· Grasping
· Bending/stooping/kneeling
· Driving
Other:
This job description is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Nothing in this job description restricts Management’s right to assign or reassign duties and responsibilities to this job at any time.