- The Regulatory Specialist II is an intermediate level position supporting regulatory affairs in clinical trial research.
- Incumbents are responsible for coordinating and supporting regulatory affairs activities for non-interventional and interventional trials for IRB submission.
- Incumbents may support an extensive and complex portfolio of trials.
- Duties include:
- Supports clinical research team (physicians, nurses, etc.) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
- Documents any exceptions to compliance standards.
- Manages new submissions, amendments, safety reports, and continuing review activities.
- Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports, deviations, and review of safety reports.
- Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
- Serves as primary contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).
- Provides direction and feedback to research team to ensure awareness of business practices and quality standards.
- Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
- Attends research team meetings to report on regulatory issues.
- Responsible for administrative duties corresponding to budgets and contracts.
- Performs related responsibilities as required.
- Bachelor's degree and two years of experience in a research environment, or an equivalent combination of experience, education and training.
- Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices.
- Must obtain all required training courses within one month of hiring date.
- Must possess an applicable research certification.
-
Regulatory Applications Specialist
1 week ago
Piedmont Healthcare Atlanta, United StatesJOB PURPOSE: · Supporting complex enterprise wide system(s) and departmental project objectives. Creating and controlling project plans, goals, deadlines, testing, implementation, changes, upgrades and post live support of assigned systems. Working with affected departments to e ...
-
Regulatory Applications Specialist
2 weeks ago
Piedmont Healthcare Atlanta, United States: · JOB PURPOSE: · Supporting complex enterprise wide system(s) and departmental project objectives. Creating and controlling project plans, goals, deadlines, testing, implementation, changes, upgrades and post live support of assigned systems. Working with affected departments ...
-
Sr Regulatory Applications Specialist
1 week ago
Piedmont Healthcare Atlanta, United StatesJOB PURPOSE: · Supporting complex enterprise wide system(s) and departmental project objectives. Creating and controlling project plans, goals, deadlines, testing, implementation, changes, upgrades and post live support of assigned systems. Working with affected departments to en ...
-
Sr Regulatory Applications Specialist
1 week ago
Piedmont Healthcare Atlanta, United StatesJOB PURPOSE:Supporting complex enterprise wide system(s) and departmental project objectives. Creating and controlling project plans, goals, deadlines, testing, implementation, changes, upgrades and post live support of assigned systems. Working with affected departments to ensur ...
-
Sr Regulatory Applications Specialist
1 week ago
Piedmont Clinic Atlanta, United States: · JOB PURPOSE: · Supporting complex enterprise wide system(s) and departmental project objectives. Creating and controlling project plans, goals, deadlines, testing, implementation, changes, upgrades and post live support of assigned systems. Working with affected departments ...
-
Senior Specialist, Regulatory Affairs
1 week ago
INTEGRA LIFESCIENCES HOLDINGS CORP Atlanta, United StatesChanging lives. Building Careers.Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possibl ...
-
Principal Regulatory Affairs Specialist
1 week ago
Abbott Laboratories company Atlanta, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
Principal Regulatory Affairs Specialist
1 week ago
Abbott Laboratories Atlanta, United States OTHERWorking at Abbott · At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to: · Career development with an international company where you can grow the career you dream of · Free med ...
-
Clinical Trials Regulatory Specialist I
1 week ago
Emory University Atlanta, United StatesDiscover Your Career at Emory University · Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence of o ...
-
Clinical Trials Regulatory Specialist I
1 week ago
Emory Healthcare/Emory University Atlanta, United States**Discover Your Career at Emory University** · Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence ...
-
Regulatory Affairs Specialist Project Lead I
4 days ago
Integrated Resources Atlanta, United StatesJob Title: Regulatory Affairs Specialist Project Lead I · Location: Washington D.C., DC (Fully Remote) · Duration: 06 months + · Part-Time Role- (Mon - Fri 9 AM - 1 PM EST) · Job Description: · Fully Remote Part-Time Mon - Fri 9 AM - 1 PM EST (slight flex offered for di ...
-
Regulatory Affairs Specialist Project Lead I
1 week ago
Integrated Resources Atlanta, United StatesJob Title: Regulatory Affairs Specialist Project Lead I · Location: Washington D.C., DC (Fully Remote) · Duration: 06 months + · Part-Time Role- (Mon - Fri 9 AM - 1 PM EST) · Job Description: · Fully Remote Part-Time Mon - Fri 9 AM - 1 PM EST (slight flex offered for di ...
-
Clinical Research Regulatory Specialist
1 week ago
Alcanza Clinical Research Decatur, United StatesClinical Research Regulatory Specialist (Remote with travel to Decatur, GA site as needed) · Department: Quality, Regulatory & Source · Employment Type: Full Time · Location: Accel Research Sites - Decatur, GA · Reporting To: Angeline Newcomb · Description · Alcanza is a growing ...
-
Avanos Alpharetta, United StatesCareer Opportunities: Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite Requisition ID 5871 -Posted - Alpharetta Office - United States - Quality Assurance, Regulatory & Compliance - Additional Posting Locations (1)Job Title: Principal Specialist, Regulator ...
-
Avanos Medical Alpharetta, United StatesRequisition ID:5871 · Job Title:Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite) · Job Country:United States (US) · Here at Avanos Medical, we passionately believe in three things: · Making a difference in our products, services and offers, never ceasing ...
-
Emory University Atlanta, United StatesDiscover Your Career at Emory University · Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence of o ...
-
Emory Healthcare/Emory University Atlanta, GA, United States**Discover Your Career at Emory University** · Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence ...
-
Clinical Trials Regulatory Specialist I
1 week ago
Emory Atlanta, United StatesEmory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence of our academic community. · JOB DESCRIPTION: · ...
-
Clinical Trials Regulatory Specialist II
1 week ago
Emory Decatur, United StatesEmory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence of our academic community. · JOB DESCRIPTION: ...
-
Clinical Trials Regulatory Specialist II
1 week ago
Emory Healthcare/Emory University Decatur, United States**Discover Your Career at Emory University** · Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence ...
Clinical Trials Regulatory Specialist II - Atlanta, United States - Emory University
Description
Discover Your Career at Emory UniversityEmory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future.
We welcome candidates who can contribute to the diversity and excellence of our academic community.Description
JOB DESCRIPTION:
MINIMUM QUALIFICATIONS:
Emory University is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status.
Emory University does not discriminate in admissions, educational programs, or employment on the basis of any factor stated above or prohibited under applicable law.
Students, faculty, and staff are assured of participation in University programs and in the use of facilities without such discrimination.
Emory University complies with Executive Order 11246, as amended, Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity and affirmative action.
Emory University is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
Inquiries regarding this policy should be directed to the Emory University Department of Equity and Inclusion, 201 Dowman Drive, Administration Building, Atlanta, GA 30322.Emory University is committed to providing reasonable accommodations to qualified individuals with disabilities upon request.
To request this document in an alternate format or to request a reasonable accommodation, please contact the Department of Accessibility Services at V) | TDD). Please note that one week advance notice is preferred.#J-18808-Ljbffr