Research Regulatory Specialist

Your job is more than a job

Why a Great Place to Work At LCMC Health we help you to lean into your calling by leaning in with you, ensuring you have the resources to do your job as only you can. And that begins with receiving the support you need to thrive and grow, which looks diƯerent for each person. Living out our commitment to inclusion requires providing benefits that are as diverse and unique as our workforce. It’s a responsibility we take seriously. Because we don’t just serve the New Orleans community—we’re at the beating heart of it. Whether by oƯering community health services or making medical innovations more accessible, LCMC Health is bringing a culture of wellness to the communities that matter to you. When you know you’re making an authentic impact, you give a little extra to every day— as a person, with your team, in your community—and that’s one of the reasons why you’ll be a perfect fit at LCMC Health, where giving a little something extra is at the heart of everything we do.

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.
- 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.

EXPERIENCE QUALIFICATIONS

- Required: 2 years of clinical research experience.
- Preferred: Previous experience as a regulatory coordinator for industry or non-industry clinical trials.

EDUCATION QUALIFICATIONS

- Required: Associate’s Degree (3 years of experience in research will be considered in lieu of education)
- Preferred: Bachelor's Degree

LICENSES AND CERTIFICATIONS

- 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)

KNOWLEDGE, SKILLS, AND ABILITIES

- 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.

REPORTING RELATIONSHIPS

- Does this position formally supervise employees? No

FUNCTIONAL DEMANDS

- Medium : Medium physical requirements- Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. Physical Demand requirements are in excess of those for Light Work.

PHYSICAL DEMANDS

- Sitting - Continuous (67-100% of day)
- Standing - Frequent (36-66% of day)
- Walking - Frequent (36-66% of day)
- Lifting Floor to waist level: 0-10lbs - Occasional (0-35% of day)
- Lifting Floor to waist level: 10-20lbs - Occasional (0-35% of day)
- Lifting Floor to waist level: 20-50lbs - Occasional (0-35% of day)
- Lifting Floor to waist level: 50-100lbs - Occasional (0-35% of day)
- Lifting Floor to waist level: 100+lbs - Occasional (0-35% of day)
- Lifting Waist level and above: 0-10lbs - Occasional (0-35% of day)
- Lifting Waist level and above: 10-20lbs - Occasional (0-35% of day)
- Lifting Waist level and above: 20-50lbs - Occasional (0-35% of day)
- Lifting Waist level and above: 50-100lbs - Occasional (0-35% of day)
- Lifting Waist level and above: 100+lbs - Occasional (0-35% of day)
- Carrying objects - Frequent (36-66% of day)
- Push/pull - Frequent (36-66% of day)
- Twisting - Frequent (36-66% of day)
- Bending - Frequent (36-66% of day)
- Reaching forward - Frequent (36-66% of day)
- Reaching overhead - Frequent (36-66% of day)
- Keyboard use/repetitive motion - Continuous (67-100% of day)
- Talk or hear - Continuous (67-100% of day)

SENSORY REQUIREMENTS

- Near Vision - Accurate 20/40
- Far Vision - Accurate 20/40

OCCUPATIONAL EXPOSURE RISK POTENTIAL

- Bloodborne pathogens - Not Anticipated
- Chemical - Not Anticipated
- Airborne communicable diseases - Not Anticipated
- Extreme temperatures - Not Anticipated
- Radiation - Not Anticipated
- Uneven surfaces or elevations - Reasonably Anticipated
- Extreme noise levels - Not Anticipated
- Dust/particular matter - Not Anticipated
- Other (List) - Not Anticipated

POPULATION SERVED

- Neonate/Infant up to 1 year: No
- Youth (1yr to 15 yrs): No
- Adult (16 and up): No

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

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.