Regulatory Relations Specialist jobs in Tennessee
Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
Recently Added Regulatory Relations Specialist jobs
Regulatory Specialist
- Holston Medical Group, PC
-
Kingsport, TN
FULL_TIME
-
If you are a motivated and reliable person with exceptional customer service skills and the ability to thrive in a fast-paced environment, come join Holston Medical Group. We are looking for friendly, courteous employees to ensure a positive patient experience and welcome a teamwork environment.
WHAT WE OFFER:
- Company paid Life and Accidental Death and Dismemberment Insurance
- Company paid Long Term Disability Insurance
- 401(k) and Roth Retirement plan with Company Contributions
- Medical, Dental, Vision, and additional Life and STD Insurance
- Health Savings Account Plan with company contributions
- Paid time off
- Paid Sick time
- Paid Holidays
- Employee discounts
- And more!
General Summary:
The Regulatory Specialist is responsible for Submitting all required information, materials, reports, regulatory documents as required by the sponsor/ funding organization, and regulatory authority(ies)managing clinical research activities.
Main Responsibilities:
- Follow HMG-CR SOPs regarding Regulatory and associated processes.
- Submitting all required information, materials, reports, regulatory documents as required by the sponsor/ funding organization, and regulatory authority(ies).
- Ensuring that the study is conducted under the oversight of a qualified IRB.
- For each study, create a series of file folders or start a binder for documents collected during the study (Study Binder)
- Make certain all CVs and medical licenses are current.
- Work with the research coordinator and PI to compile a study summary for training prior to study start-up.
- Track and submit to IRB (where appropriate) all IND safety reports generated during the study (until IRB close-out)
- Closely monitor communication with the IRB and Sponsor for required updated documentation and corrections.
- Maintain copies of all training certificates.
- Develop and maintain updated CVs for all study personnel.
- Maintain and update the file folders or binder as necessary, adding appropriate regulatory documents as they are generated or received.
- Work closely with the IRB, sponsor, and coordinator for submission and approval of all study documents and advertising.
- Obtain financial disclosure information and submit to the study sponsor.
- Accurately generate a form ‘1572’ for each study and update as required.
- Check and record temperatures for investigational drug storage and immediate report any temperature deviations to the PI, DOR, and Team Leader.
- Order and/or obtain dry-ice.
- Work closely with the study team to report regulatory study status.
- Participate in management meetings.
- Ensure that subject records and regulatory files are kept confidential and are stored in a secure, limited-access location.
- Document phone conversations that address the study and/or regulatory, legal, financial matters.
- Work with the Director of Research and Financial Coordinator to determine subject stipend and submit to the IRB for approval.
- When the study is over, review the contents of regulatory files and subject records for completeness by comparing with the checklists. (SOP attachment PM-306-A)
- Keep originals or photocopies of all relevant documentation, including facsimile confirmations and e-mail correspondence and file in the study binder with appropriate documents.
- Copy sponsor/CRO on IRB communications such as SAEs, IND safety reports, IRB acknowledgment of reports received, amendment approvals, revised informed consent form, continuing approval for study.
- Work with the Sponsor, Director of Research, and IRB for development of consent.
- Prior to initiation of study procedures, complete the IRB application and submit to the IRB along with the protocol, informed consent, recruitment material, and other information as required by the IRB.
- Confirm whether or not the sponsor/CRO expects all approval documentation to be in place prior to the Study Initiation Visit or not. If the sponsor provides a consent form, adapt the language to meet HMG-CR requirements. Consult with the sponsor/CRO , if needed, to reconcile local requirements with central requirements. Verify that all required and additional elements of the informed consent form are incorporated by using the Informed Consent Checklist (SOP Attachments SM 402-B, SM 402-C) and inserting the appropriate language as required by the IRB.
- Check fax machines routinely during working days for received faxes that contain confidential information.
- Search for potential subjects using database query, when requested by Process Specialist.
- Work with Team Leaders to assist with document filing when required.
Education/Experience/Knowledge:
- High School Diploma or equivalent required
- 1-2 years' experience in a medical office, preferred
- Experience in the conduct of clinical research preferred but not required for application.
- Interpersonal and communication skills - interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
We are an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, age, national origin or disability.
Education
Preferred- High School or better in General Studies
- Technical/other training or better in Nursing
- 4 Days Ago
Regulatory Specialist
- HMG
-
Kingsport, TN
FULL_TIME
- If you are a motivated and reliable person with exceptional customer service skills and the ability to thrive in a fast-paced environment, come join Holston Medical Group. We are looking for friendly,...
- 6 Days Ago
Regulatory Specialist II
- Hueman PE Talent Solutions
-
Brentwood, TN
FULL_TIME
- Resource Environmental Solutions (RES) is looking for a Regulatory Specialist II with at least 2 years of experience for our Nashville, TN, Athens, GA, or Macon, GA offices. RES is operating in a uniq...
- 27 Days Ago
Customer Relations Specialist
- Regal Cinemas, Inc
-
Knoxville, TN
FULL_TIME
- Essential Duties and Responsibilities include the following. Other duties may be assigned. Regular and Consistent Attendance Provide quality customer service in a prompt, responsible and professional ...
- 2 Days Ago
Customer Relations Specialist
- Regal
-
Knoxville, TN
FULL_TIME
- Essential Duties and Responsibilities include the following. Other duties may be assigned. Regular and Consistent Attendance Provide quality customer service in a prompt, responsible and professional ...
- 4 Days Ago
Public Media Relations Specialist
- Rutherford County Government
-
Murfreesboro, TN
FULL_TIME
- Annual Salary Range: $40,939 - $43,934 The purpose of this classification is to perform public relations and media relations for the Rutherford County Pet Adoption & Welfare Services (PAWS) department...
- 5 Days Ago
Regulatory Relations Specialist jobs at Popular Companies
Regulatory Relations Specialist
- Groupe BPCE
-
New York, NY
- Poste et missions Regulatory Relations provides centralized management of activities with the firm's local regulators. A...
- 5/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Intellectt Inc
-
Santa Clara, CA
- Hello,Hope you are doing well.This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and...
- 5/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Healgen Scientific Limited
-
Houston, TX
- Regulatory Affairs Specialist Regulatory Affairs | Houston, TX Apply Now (upload_80.html) Back to Search Join us on our ...
- 5/9/2024 12:00:00 AM
Regulatory Affairs Specialist
- Medline Industries
-
Winnetka, IL
- JOB SUMMARY: Under general supervision, the Regulatory Specialist is responsible for planning and executing global regul...
- 5/9/2024 12:00:00 AM
Regulatory Affairs Specialist
- BioTalent
-
- Position Summary The primary responsibility of the Regulatory Affairs Specialist is to manage and perform regulatory sub...
- 5/9/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Scarborough, ME
- Regulatory Affairs Specialist II – On-site in Scarborough, ME RESPONSIBILITIES Implement & maintain the effectiveness of...
- 5/8/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 5/7/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Lake Forest, IL
- Regulatory Affairs Specialist – Onsite in Lake Forest, IL Must be able to work W2 Summary Our client, a Fortune-500 Medi...
- 5/6/2024 12:00:00 AM
About Tennessee
Tennessee borders eight other states: Kentucky and Virginia to the north; North Carolina to the east; Georgia, Alabama, and Mississippi on the south; Arkansas and Missouri on the Mississippi River to the west. Tennessee is tied with Missouri as the state bordering the most other states. The state is trisected by the Tennessee River.
The highest point in the state is Clingmans Dome at 6,643 feet (2,025 m). Clingmans Dome, which lies on Tennessee's eastern border, is the highest point on the Appalachian Trail, and is the third highest peak in the United States east of the Mississippi River. The ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$68,737 to $94,364
Most Popular Cities in Tennessee for Regulatory Relations Specialist Jobs
What does a Regulatory Relations Specialist do?
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020
Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards. This includes assisting with the management of regulatory examinations, inquiries and meetings. Additional responsibilities include.
December 09, 2019