Research Regulatory Specialist

LCMC Health•Mason, MI

9d•Onsite

About The Position

Your job is more than a job. At LCMC Health, we help you lean into your calling by leaning in with you, ensuring you have the resources to do your job as only you can. This begins with receiving the support you need 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.

Requirements

2 years of clinical research experience.
Associate’s Degree (3 years of experience in research will be considered in lieu of education)
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.

Nice To Haves

Previous experience as a regulatory coordinator for industry or non-industry clinical trials.
Bachelor's Degree
Certification Name: Certified Clinical Research Associate of Certified Clinical Research Professional
Issuer: Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP)

Responsibilities

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