-
Regulatory Specialist
3 days ago
Kinsa Group Dallas, United StatesKinsa is recruiting for a: Regulatory Specialist - Food industry · Location: Onsite in Dallas, Texas · Our client is a manufacturer of cooked meat products with a new opening for a Regulatory Specialist to join their team in Dallas, Texas. You will develop and oversee the reg ...
-
Regulatory Specialist
3 weeks ago
International Foodservice Manufacturers Association Dallas, United StatesRegulatory Specialist · Serving as a crucial resource in ensuring that products meet labeling and food safety laws for successful market entry. · Responsible for overseeing the supplier program and spec management and product approval while helping the business expand and reach t ...
-
Regulatory Specialist
2 weeks ago
Oncor Electric Delivery Dallas, United StatesSalary Range: $94,284 - $125,712Relocation: Yes · Summary · Responsible for a broad range of compliance and risk support activities, including primary responsibility for ensuring that Oncor's newly identified affiliate companies are posted in compliance with Public Utility Commi ...
-
regulatory specialist
3 weeks ago
Methodist Health System Dallas, United StatesHours of Work : · 8am-5pm · Days Of Week : · M-F · Work Shift : · Job Description : · Your Job: · The Regulatory Specialist will perform expertise in the regulatory component of all clinical research trials to include, but not limited to; Phase II and IV clinical, investig ...
-
Regulatory Specialist
2 weeks ago
Oncor Electric Delivery Dallas, United StatesResponsible for a broad range of compliance and risk support activities, including primary responsibility for ensuring that Oncor's newly identified affiliate companies are posted in compliance with Public Utility Commission of Texas (PUCT) requireme Compliance, Regulatory, Speci ...
-
Regulatory Specialist
3 weeks ago
International Foodservice Manufacturers Association Dallas, United StatesRegulatory SpecialistServing as a crucial resource in ensuring that products meet labeling and food safety laws for successful market entry.Responsible for overseeing the supplier program and spec management and product approval while helping the business expand and reach their b ...
-
RN Policy and Regulatory Specialist-Remote
1 week ago
AccentCare Dallas, United StatesOverview: · Find Your Passion and Purpose as a Policy and Regulatory Specialist-RN · Reimagine Your Career in Corporate Healthcare · As a professional, you know that what you do impacts you as much as our patients and their families, and at AccentCare, we are united in our rel ...
-
Regulatory Affairs Specialist
3 weeks ago
Spero Technology Dallas, United StatesWhat You Will DoAs a Quality Control Technician, you will perform quality control inspections and testing of in-house fabricated Instruments and control panels, under UL 508A & 698A standards.A Typical Day atUnderstanding of electrical wiring, fabrication, and testing of control ...
-
Clinical Research Regulatory Specialist
3 weeks ago
Baylor Scott & White Health Dallas, United StatesShift: 8AM-5PM · Location: Sammons Cancer Center · 3410 Worth St, Dallas, 75246 · Dept: Oncology · JOB SUMMARY · The Clinical Research Regulatory Specialist helps clinical research activities through the development of protocol-specific documents and reports for research activiti ...
-
Bank of America Dallas, United States Full timeDescription · : · Manages more complex specialty assets within The Private Bank Group with a full and in-depth understanding of all fiduciary aspects associated within a given segment of specialty assets, i.e., real estate, farm & ranch, timberland, oil & gas, private businesses ...
-
Regulatory Affairs Specialist
1 week ago
Resource Informatics Group Irving, United StatesRole: Regulatory Affairs Specialist · Location: Austin, TX (HYBRID) · Duration: 12+ Months · Primary Responsibilities:Monitor and participate in stakeholder processes for ERCOT independent system operator, provide Shell Energy and Renewable and Energy Solutions (R&ES) business ...
-
Quality & Regulatory Specialist
2 days ago
Formulife Allen, United StatesPosition Summary · The Quality and Regulatory Specialist ensures the highest standards of product quality and regulatory compliance. This role involves implementing and maintaining quality management systems, conducting audits, and overseeing compliance with FDA, GMP, and other r ...
-
Regulatory Affairs Specialist
3 weeks ago
Astrix Fort Worth, United StatesExciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care. · Regulatory Affairs Specialist III · • Support the NBL Manager in ...
-
Regulatory Affairs Specialist
3 weeks ago
TalentBurst, an Inc 5000 company Fort Worth, United StatesPosition: Regulatory Affairs Specialist III, Req#: 2797-1 · Location: Fort Worth, TX (100% Onsite) · Duration: 6+ Months Contract · Job Description: · Must Haves: · Must have Medical Device experience. (Not Pharma) · European MDR Experience · Manufacturing background · 4 Years ...
-
Regulatory Affairs Specialist
3 weeks ago
eTeam Fort Worth, United StatesMust Haves: · • Must have Medical Device experience. (Not Pharma) · • European MDR Experience · • Manufacturing background · • 4 Years of experience minimum (pure medical devise) · Job Description: · • Support the NBL Manager in Lifecycle Change Management projects. · • Pro-activ ...
-
Regulatory Affairs Specialist
4 days ago
TCWGlobal Fort Worth, United StatesRegulatory Affairs Specialist (R&D/QA) · Fort Worth, TX *Local candidates- 3 days on site/2 days remote) · $43-$45hr (Weekly pay + Benefits) · 1yr contract (Excellent potential for extension or permanent) · Full-time- M-F 8am-5pm · Our client is a global team of innovators, lead ...
-
Regulatory Affairs Specialist
1 week ago
TCWGlobal Fort Worth, United StatesJob Description · Job DescriptionRegulatory Affairs Specialist (R&D/QA) · Fort Worth, TX *Local candidates- 3 days on site/2 days remote) · $43-$45hr (Weekly pay + Benefits) · 1yr contract (Excellent potential for extension or permanent) · Full-time- M-F 8am-5pm · Our client is a ...
-
Regulatory Affairs Specialist III
3 weeks ago
Sunrise Systems Inc Fort Worth, United StatesJob Title: Regulatory Affairs Specialist III · Job ID: · Location: Fort Worth, TX · Duration: 06 months on W2 Contract · Must Haves:Must have Medical Device experience. (Not Pharma) · European MDR Experience · Manufacturing background · 4 Years of experience minimum (pure medic ...
-
Regulatory Affairs Specialist III
3 weeks ago
Mitchell Martin Fort Worth, United StatesOur client, is a Swiss-American pharmaceutical and medical device company, is seeking a Regulatory Affairs Specialist III · Location: Fort Worth, TX · Position Type: Contract · Job Description: · • Support the NBL Manager in Lifecycle Change Management projects. · • Pro-actively ...
-
Regulatory Affairs Specialist III
3 weeks ago
TalentBurst Fort Worth, United StatesJob Title: Regulatory Affairs Specialist III · Duration: 06 months · Location: Fort Worth, TX · Must Haves: · Must have Medical Device experience. (Not Pharma) · European MDR Experience · Manufacturing background · 4 Years of experience minimum (pure medical devise) · Job Descri ...
Submission for the position: Clinical Research Regulatory Specialist - Dallas, United States - Baylor Scott & White Healthcare
Description
Shift: 8AM-5PMLocation: Sammons Cancer Center3410 Worth St, Dallas, 75246Dept: OncologyJOB SUMMARYThe Clinical Research Regulatory Specialist helps clinical research activities through the development of protocol-specific documents and reports for research activities from initial submission through study closure.
The primary focus for this position is on development, submission, maintenance, filing and reporting of regulatory documents to achieve and maintain compliance with all internal, external and federal policies and regulations pertinent to research involving human subjects.
This position also provides regulatory guidance and direction to internal clinical research programs to ensure compliance with all applicable policies, procedures and regulations.
ESSENTIAL FUNCTIONS OF THE ROLEPrepares, facilitates and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy.
Ensures that all documents are complete and that the submission packet meets the IRB's revision submission requirements prior to sending to the IRB.
Follows-up, communicates and facilitates responses to queries of the IRB, Sponsor and other committees as a result of their review of submissions.
Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state and local agencies governing biomedical research.
Obtains Sponsor approval of consent form prior to submission to the IRB.Facilitates and coordinates the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by partnering with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents.
Ensures that regulatory binders are audited and maintained.Tracks workload and status of pending protocols and associated upholding documents in order to provide efficient customer service to the Research team.
Participates in quality assurance (QA) and control programs related to overall project and patient data, as needed. Oversees QA initiatives for the department to help research staff and managers during sponsor and FDA audits.Facilitates investigator-initiated research by ensuring all regulatory requirements are met, to include ensuring requirements for trial registration, results and reporting are completed in a timely manner consistent with federal regulations.
KEY SUCCESS FACTORSProven written and oral communication skills.Proven leadership skills in project management, including project management tools and techniques.
Exceptional computer skills, including Microsoft Office, Excel and PowerPoint.
Ability to manage time reactive projects in order to meet deadlines.
Excellent ability to establish and maintain effective working relationships.
BENEFITSOur competitive benefits package includes the following.
Immediate eligibility for health and welfare benefits401(k) savings plan with dollar-for-dollar match up to 5%Tuition ReimbursementPTO accrual beginning Day 1Note: Benefits may vary based upon position type and/or levelSQUALIFICATIONS- EDUCATION - Associate's or 2 years of work experience above the minimum qualification- EXPERIENCE - 3 Years of Experience
