Research Regulatory Specialist Senior

Your job is more than a job.

The Research Regulatory Specialist Senior is responsible for providing support for implementation of clinical trials. Performs a wide variety of start-up activities integral to the successful application and acceptance of essential regulatory documents for clinical research protocols. Responsible for ensuring submission of documents to pharmaceutical sponsors, Institutional Review Board (IRB), and contract research organizations (CRO) as applicable. Serves as a liaison between the various sponsors, IRB, and internal departments/staff in order to implement clinical trials and research projects with minimal protocol deviations. Assists and guides new and junior team members.

GENERAL DUTIES

Protocol Regulatory Management:

• Manages study regulatory documents such as limited FDA Form 1572, Protocol Amendments, safety reports, site delegation signature logs, etc. Completes all regulatory documents needed in preparation for submission to the pharmaceutical sponsor and/or CRO. Completes all documents needed in preparation for submission to the IRB. These include submission letters, questionnaires, generic advertisements, etc. Regularly and as needed, meets with the appropriate leader to discuss new studies and the updating of current studies. Assists with site visits and prepares for audits as needed. Prepares monthly IRB summaries for current studies and prepares weekly summary of tasks reports and regulatory status reports. Manages and updates all nursing and medical licenses on file for investigators, research coordinators, and other staff.

Data Management and Reporting:

• Assists with completion of data reporting as needed. Submits monthly study financial reports.

Quality Assurance and Audit:

• Participates in internal quality assurance activities. Reviews clinical research data provided by physicians and nurses, checking for consistency and accuracy. Responsible for correcting errors. Coordinates audits for assigned protocols.

Mentorship:

• Mentors junior staff and assists the clinical team in the development of trial specific training tools for the study staff.

EXPERIENCE QUALIFICATIONS

• Required: 5 years of experience in clinical research.
• Preferred: Previous experience as a regulatory coordinator for industry or non-industry clinical trials.

EDUCATION QUALIFICATIONS

• Required: Associate’s Degree (7 years of experience in research will be considered in lieu of education).
• Preferred: Bachelor's Degree.

KNOWLEDGE, SKILLS, AND ABILITIES

• Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments (i.e., Word, Excel, Internet).
• Ability to communicate quickly and effectively with the Institutional Review Board is required.

WORK SHIFT:

Days (United States of America)

LCMC Health is a community. 

Our people make health happen. While our NOLA roots run deep, our branches are the vessels that carry our mission of bringing the best possible care to every person and parish in Louisiana and beyond and put a little more heart and soul into healthcare along the way. Celebrating authenticity, originality, equity, inclusion and a little “come on in” attitude is the foundation of LCMC Health’s culture of everyday extraordinary

About University Medical Center

University Medical Center, a world class academic medical center in LCMC Health’s incredible community of care, is the largest medical training center for healthcare professionals in Louisiana and has long served as the region’s safety net hospital for poor and underserved communities for 300+. Learn more about University Medical Center’s legacy and our vision of becoming the epicenter of medical care, education, and research.

Your extras

• Deliver healthcare with heart. 
• Give people a reason to smile. 
• Put a little love in your work. 
• Be honest and real, but with compassion.  
• Bring some lagniappe into everything you do. 
• Forget one-size-fits-all, think one-of-a-kind care. 
• See opportunities, not problems – it’s all about perspective. 
• Cheerlead ideas, differences, and each other.