- Format, collect, and timely preparation of documents for regulatory submissions in accordance with FDA and trial sponsor specifications. Track collection progress through regulatory workflows.
- Maintain paper and/or electronic study trial file. Continually update the files and assist with the preparation for audits and sponsor visits.
- Assist with notifying IRB, study team, sponsors and regulatory agencies if applicable, of trial changes, enrollment status, and protocol deviations including the submission of continuing review data.
- Provide guidance and instructions to research personnel on regulatory affairs requirements and procedures with assistance from the supervisor. Assists with revisions to the Informed Consent Form (ICF) in compliance with sponsor and IRB requests.
- Assist with grant and contract support including submission of legal documents and associated routing forms to Office Research Administration and OU Medical Center.
- Maintain a working knowledge of regulations, submission requirements and processes for multiple regulatory systems.
- Adapt and adjust to changing regulations and processes while maintaining standardized regulatory operations and establishing clear documented workflows.
- Communicate important regulatory and study related information to the Research Team, Sponsors or regulatory authorities throughout the regulatory process.
- Independently manage and maintain a palette of studies with minimal supervision. Ensuring studies continue to meet regulatory, GCP and institutional guidelines and processes.
- Track milestones and ensure deadlines are met on multiple projects with minimal supervision.
- Perform various duties as needed to successfully fulfill the functions of the position.
- 12 months of regulatory and/or compliance experience
- Advanced knowledge of compliance and regulatory concepts, guidelines, and principles.
- Advanced level of proficiency with Microsoft Office Suite and other software systems.
- Must be detail oriented and have excellent organizational skills.
- Ability to communicate verbally and in writing.
- Physical: Sit for prolonged periods. Communicate effectively and actively listen. Engage in repetitive motion. Use of computer and telephone. Stand, stoop, bend, and reach.
- Environmental: Standard office environment.
-
Oncology Research Regulatory Specialist
3 weeks ago
The University of Oklahoma Norman, United StatesOU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of c ...
-
Senior Oncology Regulatory Specialist
3 days ago
University of Oklahoma Oklahoma City, United States Full timeJob Description · --- OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive th ...
-
Regulatory Compliance Specialist
5 days ago
Continental Resources Edmond, United StatesJob Summary · Responsible for state and federal operational permitting, compliance reporting and various other regulatory filing requirements with multiple governmental agencies. Coordinates with operational teams to ensure full compliance with governmental rules/regulations. Pr ...
-
Senior Oncology Regulatory Specialist
1 week ago
The University of Oklahoma Oklahoma City, United StatesOU Health Stephenson Cancer Center is Oklahomas only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of ca ...
-
Senior Oncology Regulatory Specialist
1 week ago
University of Oklahoma Oklahoma City, United StatesJob Description · OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the hi ...
-
Senior Specialist Regulatory Affairs
3 days ago
Organon Oklahoma City, United StatesJob Description · Organon is hiring Senior Specialist Regulatory Affairs. · The Senior Specialist will be responsible for all RA submission requirements and PV activities for their assigned product portfolio as applicable. He/she is the regulatory contact with local stakeholders ...
-
Senior Oncology Regulatory Specialist
2 weeks ago
University of Oklahoma Oklahoma City, United StatesJob Description - *Senior Oncology Regulatory Specialist · *Senior Oncology Regulatory Specialist · - · Job Number: · 241388 · Organization · Job Location · Schedule · Schedule · : · Full-time · Work Schedule · : · Monday-Friday 8am-5pm · Work Type · : · Onsite · Sal ...
-
Senior Oncology Regulatory Specialist
2 weeks ago
University of Oklahoma Edmond, United StatesOU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)Designated Cancer Center, and one of only 72 NCI - Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients re Regulatory, Specialist, Clini ...
-
IT Asset Manager
3 weeks ago
InsideHigherEd Norman, United StatesOrganization · Title- IT Asset Manager · Team- IT Services · Work Type- Onsite · Are you a driven IT professional continuously looking for innovative ways to fine-tune processes and systems? · At OU IT, you will be a part of an organization that recognizes and rewards the contrib ...
-
RI Coder II
4 days ago
Norman Regional Health System Norman, United StatesOverview: · The coding team at Norman Regional Health System, as a component of the Documentation Integrity Department, works to provide timely and compliant coding for all patient encounters. We strive to tell the story of the patient's experience through the use of accurate and ...
-
Oncology Data Specialist
3 weeks ago
The University of Oklahoma Norman, United StatesOU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of c ...
-
Oncology Data Specialist
3 days ago
The University of Oklahoma Norman, United StatesOU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of c ...
-
Sr. Oncology Data Specialist
3 weeks ago
The University of Oklahoma Norman, United StatesOU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of c ...
-
Financial Aid Compliance Specialist
3 weeks ago
The University of Oklahoma Norman, United StatesThe Financial Aid Compliance Specialist reports directly to the Executive Director of Financial Aid Services and Chief Student Financial Aid Officer and supports the Executive Director with the responsibility of ensuring compliance with federal and state financial aid rules and r ...
-
Senior Roadway Engineer
5 days ago
AtkinsRéalis Norman, United StatesJob Description · Why join us? · It's an exciting time at AtkinsRéalis We are rapidly growing in the US. Our company purpose is to build a better world for our planet and its people. We recognize the importance of making sure that our clients and employees, feel this purpose ever ...
-
RI Coder II
2 weeks ago
Norman Regional Health System Norman, OK, United States Full time $17.39 - $28.40Overview: Applying for this role is straight forward Scroll down and click on Apply to be considered for this position. The coding team at Norman Regional Health System, as a component of the Documentation Integrity Department, works to provide timely and compliant coding for al ...
-
Senior Professional IT Security
2 weeks ago
Titan Industries Blanchard, United StatesAt Mazars, people come together to achieve great things. Growth is our firm course: founded in Europe and at home in the world, we are now present in 95 countries. Our experts work with trust to actively support our clients in sustainable business development - from auditing, tax ...
-
IT Asset Manager
2 weeks ago
University of Oklahoma Norman, United StatesJob Description · Title- IT Asset ManagerTeam- IT ServicesWork Type- Onsite · Are you a driven IT professional continuously looking for innovative ways to fine-tune processes and systems? · At OU IT, you will be a part of an organization that recognizes and rewards the contrib ...
-
IT Specialist
3 weeks ago
Department Of Commerce Norman, United States Full timeSummary · This position is within the National Oceanic and Atmospheric Administration (NOAA), National Weather Service (NWS), National Centers for Environmental Prediction (NCEP), with 1 vacancy in Norman, OK. · This position is also announced under vacancy #NWS NCEP DE, which is ...
-
Director of Facilities Management
3 weeks ago
Addison Group Oklahoma, United StatesDirector of Biomedical Equipment & Facilities Services Management Summary · Under the direction of the Associate Vice President of Facility Operations is responsible for the operational excellence of the department through a primary focus on equipment availability, timely preven ...
Oncology Research Regulatory Specialist - Norman, United States - The University of Oklahoma
Description
OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 NCI-Designated Cancer Centers in the United States.
This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options.
At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you The Oncology Research Regulatory Specialist position, under direct supervision, performs tasks with discretion and asks questions to determine the proper course of action while following established standards.
Assists with coordinating regulatory and Institution Review Board (IRB) activities of clinical research, revisions to the Informed Consent Form, and grant support.
Adheres to University Compliance program, Code of Ethics, and Business Standards.Learn more about the Stephenson Cancer Center's Clinical Trials Office here.
Duties:
Required Education:
Associate's degree
Equivalence/Substitution:
Will accept 24 months of equivalent experience in lieu of the Associate's
degree for a total of 36 months experience.
Skills:
Working Conditions:
Why You Belong at the University of Oklahoma: The University of Oklahoma fosters an inclusive culture of respect and civility, belonging, and access, which are essential to our collective pursuit of excellence and our determination to change lives.
The unique talents, perspectives, and experiences of our community enrich the learning, and working environment at OU, inspiring us to harness our innovation, creativity, and collaboration for the advancement of people everywhere.
Equal Employment Opportunity Statement:
The University of Oklahoma, in compliance with all applicable federal and state laws and regulations, does not discriminate based on race, color, national origin, sex, sexual orientation, genetic information, gender identity, gender expression, age, religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures.
This includes, but is not limited to, admissions, employment, financial aid, housing, services in educational programs or activities, and health care services that the University operates or provides.
