Job Description

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Your job is more than a job.

The Research Regulatory Specialist 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 timely 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.

Your every day

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. Regularly 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.

This is intended to describe the general nature and level of work performed by employees assigned to this department. This is not an exhaustive list of all duties and responsibilities, and LCMC Health reserves the right to amend and change responsibilities to meet organizational needs as necessary

Your must haves

• Required: 2 years of clinical research experience.
• Preferred: Previous experience as a regulatory coordinator for industry or non-industry clinical trials.
• Required: Associate's Degree (3 years of experience in research will be considered in lieu of education)
• Preferred: Bachelor's Degree
• Ability to work consistently and effectively as part of a high-performance work team.
• Ability to effectively devote keen and acute attention to detail.
• Demonstrated ability to operate basic office equipment including (but not limited to) copying machines, facsimile machines, multi-line telephones, and computers.
• Strong written communication skills, including exceptional spelling abilities and ability to utilize email without major issues.
• Strong verbal skills.
• Strong interpersonal skills.
• Highly motivated “self-starter” with the ability to exercise initiative. ability to work as a team player as well as independently while managing a variety of study-related projects simultaneously.
• 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.
• Certification Name: Certified Clinical Research Associate of Certified Clinical Research Professional
  • Preferred
  • Issuer: Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP)
  • Licensure Speciality:
  • Entity:

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 East Jefferson General Hospital

East Jefferson General Hospital, a landmark of LCMC Health's incredible community of care, has been the go-to hospital for health, wellness, and one-of-a-kind care in East Jefferson Parish for over 50 years. And we're only beginning to realize our greatest potential. Learn more about East Jefferson General Hospital and our legacy, our future, and our national recognition as a Nurse Magnet Hospital.

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.
• Love what makes you, you - because we do

You are welcome here.

LCMC Health is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

The above job summary is intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. LCMC Health reserves the right to amend and change responsibilities to meet organizational needs as necessary.

Simple things make the difference.

1. To get started, take your time to fully and accurately complete the application for employment. Incomplete applications get bogged down and are often eliminated due to missing information.

2. To ensure quality care and service, we may use information on your application to verify your previous employment and background.

3. To keep our career applications up-to-date, applications are inactive after 6 months and, therefore, require a new application for employment to be completed.

4. To expedite the hiring process, proof of citizenship or immigration status will be required to verify your lawful right to work in the United States.

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