Regulatory Affairs Specialist jobs in Jacksonville, FL
Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Specialist jobs
- East Coast Institute for Research
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Jacksonville, FL
FULL_TIME
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Come work with a growing, multi-site clinical research team!
East Coast Institute for Research (ECIR) is dedicated to developing ground-breaking new research to benefit our communities. Our research involves the latest medications and devices not yet available to the general public and is conducted at our state-of-the-art facilities in Northeast Florida and Georgia. With over 15 years of experience, ECIR maintains a positive reputation with our sponsors, our partnering clinics and our patients.
We currently have 7 research sites and continue to grow! We’re a small, family-oriented company that cares about our employees and provides an environment where learning and growth is available and encouraged. We have a clear growth plan for our clinical research staff and offer reimbursement for the credentialing process as well as other training to help our clinical staff feel prepared and successful.
We offer great health benefits that are available in less than 30 days including medical (with an HSA option with company match), dental, vision, life, and disability, so that you can make sure you and your family’s health are taken care of. We also provide ample paid time off, paid holidays, and flexible schedules. Our 401K option is available to employees after 3 months and has a company match.
Engaging with each other through continued training and fun group experiences is important to us. We try to get all 7 sites together quarterly to do team building, continued education, and just have some fun!
We’ve told you about us, now tell us about you! Apply today!
PURPOSE
Under the direction of the Director of Compliance, this position assists with regulatory activities within the company. This position works in close coordination with the Director of Compliance, Chief Operations Officer, Clinical Research Coordinators, Clinical Research Assistants, Investigators, Clinical Research Associates (CRAs), Sponsors, and Clinical Research Organizations (CROs) to carry out the trial.The regulatory specialist will work as an integral member of ECIR research staff maintaining day-to-day regulatory tasks within ECIR site network.. This includes assisting with the execution of clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor, CRO, and ECIR SOP’s and any relevant local guidelines and regulations.
RESPONSIBILITIES- Identify noncompliance issues within regulatory binders.
- Meet with the research staff and investigators as needed.
- Work collaboratively with investigators and research staff to complete outstanding documents.
- Perform reviews of Investigator Site Files (ICF) for completeness and accuracy.
- Participate in sponsor, CRO, and FDA audits or inspections, including preparation, hosting, and resolution of any items.
- Prepare study Confidentiality Agreements (CDAs) with site revisions, obtain appropriate signatures, and submit in a timely manner.
- Prepare study Clinical Trial Agreements (CTAs) with site revisions, obtain appropriate signatures, and submit in a timely manner.
- Gather documents requested during Site Selection Visits (SSVs) including but not limited to copies of research staff/investigators curriculum vitae (CVs), medical licenses (MLs), Good Clinical Practice (GCP) training certificates, ECIR Standard Operating Procedures (SOPs), site equipment calibration logs, etc.
- Complete regulatory documents including but not limited to financial disclosure forms (FDFs), protocol signature pages (PSPs), Form FDA 1572s, investigator statements, informed consent forms (ICFs) etc.
- Route regulatory documents to research staff and investigators to obtain signatures and follow up, as necessary.
- Assist with the management of regulatory binders in the ECIR electronic regulatory system (Complion), including but not limited to setting up initial binders, scanning and uploading study documents, and performing quality checks.
- Create investigator curriculum vitaes (CVs) and update on a bi-annual basis or as requested.
- Obtain and maintain valid medical licenses for all investigators.
- Participate in development of company standard operating procedures (SOPs) and Guidance Documents (GDs), as needed.
- May perform other job-related duties as requested or required.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES- Sound knowledge of medical terminology.
- Sound knowledge of ICH/GCP, Regulatory requirements, FDA and HIPAA policies and practices.
- Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
- Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Meticulous attention to detail.
- Ability to maintain confidentiality.
- Strong written communication skills.
- Strong organizational skills.
- Proficient in the use of Microsoft Office, Microsoft Excel, and Adobe Acrobat.
- Ability to meet multiple and changing deadlines
- Ability to consult numerous sources for information to prepare documents.
- Fluent in spoken and written English language.
MINIMUM REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATIONS- High School diploma
- Maintaining License/Certification status with appropriate CEU’s, if applicable
- Good Clinical Practice (GCP)
- Significant experience with Microsoft Office, Microsoft Excel, and Adobe Acrobat.
PHYSICAL REQUIREMENTS- Extensive use of keyboard requiring repetitive motion of fingers.
- Regular sitting for extended periods of time.
- Occasional travel – required
- Office hours are determined by manager.
- 10 Days Ago
- ProSidian Consulting, LLC
-
Jacksonville, FL
FULL_TIME
- Company DescriptionProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry-leading practices. ProSidian se...
- 12 Days Ago
- City of Jacksonville
-
Jacksonville, FL
OTHER
- Are you looking for a position with a work/life balance? Do you want to earn four weeks off during your first year of employment? Do you want low and no cost health insurance options? If you answered ...
- 15 Days Ago
- City of Jacksonville, FL
-
Jacksonville, FL
FULL_TIME
- Job Description Are you looking for a position with a work/life balance? Do you want to earn four weeks off during your first year of employment? Do you want low and no cost health insurance options? ...
- 11 Days Ago
- Hispanic Technology Executive Council
-
Jacksonville, FL
FULL_TIME
- At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we deliver for our...
- 5 Days Ago
- Bank of America
-
Jacksonville, FL
FULL_TIME
- Job Description:At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we...
- 6 Days Ago
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0 Regulatory Affairs Specialist jobs found in Jacksonville, FL area
- Autoscribe
-
Jacksonville, FL
- Job Description Job Description About us Autoscribe Corporation is a premier payment processing company, comprised of ov...
- 4/23/2024 12:00:00 AM
- Paysafe
-
Jacksonville, FL
- About Paysafe Paysafe ("Paysafe") (NYSE: PSFE) (PSFE.WS) is a leading payments platform with an extensive track record o...
- 4/23/2024 12:00:00 AM
- DWS Group
-
Jacksonville, FL
- Employer: DWS Group Title: Senior Risk Manager – 3rd Party Risk Location: Jacksonville, FL About DWS: Today, markets fac...
- 4/22/2024 12:00:00 AM
- Department Of The Treasury
-
Jacksonville, FL
- Duties WHAT ARE THE APPEALS (AP), LARGE BUSINESS AND INTERNATIONAL (LB&I), SMALL BUSINESS SELF-EMPLOYED (SB/SE) AND TAX ...
- 4/22/2024 12:00:00 AM
- Wells Fargo
-
Jacksonville, FL
- Why Wells Fargo:This is where your career truly begins. We rank #2 overall in the country on LinkedIns Top Companies lis...
- 4/22/2024 12:00:00 AM
- Wells Fargo Bank
-
Green Cove Springs, FL
- Why Wells Fargo:Are you ready for the next step in your career? This is where it begins - at a company known for our 'We...
- 4/22/2024 12:00:00 AM
- Fidelity TalentSource LLC
-
Jacksonville, FL
- Job Description: Wealth Planner Are you passionate about helping clients with comprehensive wealth strategies? Do you lo...
- 4/21/2024 12:00:00 AM
- Dws Group
-
Jacksonville, FL
- Employer:DWS Group Title:Senior Risk Manager 3rd Party Risk Location:Jacksonville, FL About DWS: Today, markets face a w...
- 4/21/2024 12:00:00 AM
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