About the role

LCMC Health Opportunity Your job is more than a job. At LCMC Health, we help you to lean into your calling by leaning in with you, ensuring you have the resources to thrive and grow, which looks different 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 offering 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
  • PreferredIssuer: 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? NoFunctional 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 AnticipatedExtreme temperatures - Not Anticipated
  • Radiation - Not Anticipated
  • Uneven surfaces or elevations - Reasonably AnticipatedExtreme noise levels - Not Anticipated
  • Dust/particular matter - Not Anticipated
  • Other (List) - Not Anticipated
  • Population Served
  • Neonate/Infant up to 1 year: NoYouth (1yr to 15 yrs): NoAdult (16 and up): NoWork 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

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JOB OVERVIEW

Experience level

Senior

Location

New Orleans, LA

Occupation

Regulatory Affairs Specialists

Industry

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Posted

13 days ago

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