Regulatory Affairs Coordinator II

3 weeks ago


Fort Worth, United States Actalent Full time

Regulatory Affairs Coordinator II

Job Description:

Looking to hire a hybrid individual with strong regulatory and clinical research experience to act as a Regulatory Affairs Coordinator II to support an ongoing clinical trials . Please note, as the position and study progress, additional job duties will likely be added that are not listed in this description. A candidate must help the site and study wherever needed depending on the specific assignment.

Responsibilities:

+ Conducts study start-up activities and prepares/maintains all regulatory documents

+ Coordinates with the IRB and Sponsors, preparing submissions, answering questions

+ Helps identify and recruit patients and assists with informed consent process

+ Prepares documents and facility for external audits by the sponsor or various regulatory agencies

+ Evaluates protocols with the PI

+ Prepares study invoices and billing, and works with the PI to assist with grant preparation and reporting

+ Performs a variety of other regulatory and coordinator duties as required

Qualifications:

+ Experience as a Regulatory Coordinator or Clinical Research Coordinator, ideally from a hospital/academic setting

+ Experience with electronic medical records (EMR)

+ Experience with electronic data capture (EDC) systems

+ Experience with IRB submittals and other regulatory duties

+ CRC and RAPS certification preferred but not required

Additional Details:

Location: Fort Worth, TX

Duration: 9-month contract to hire

Hourly pay range: $25-32/hr

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

+ Hiring diverse talent

+ Maintaining an inclusive environment through persistent self-reflection

+ Building a culture of care, engagement, and recognition with clear outcomes

+ Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.



  • Fort Worth, United States Actalent Full time

    Regulatory Affairs Coordinator Job Description: Looking to hire a hybrid individual with strong regulatory and clinical research experience to act as a Regulatory Affairs Coordinator II to support an ongoing clinical trials . Please note, as the position and study progress, additional job duties will likely be added that are not listed in this description....


  • Fort Worth, United States Actalent Full time

    Regulatory Affairs Coordinator Job Description: Looking to hire ahybrid individualwith strong regulatory and clinical researchexperienceto act as aRegulatory Affairs Coordinator IItosupport an ongoingclinical trials . Please note, as the position and study progress, additional job duties will likely be added that are not listed in this description. A...


  • Fort Worth, Texas, United States TCWGlobal Full time

    Regulatory Affairs Specialist (R&D/QA)Location: Remote with On-Site RequirementsCompensation: $43-$45/hr (Weekly pay + Benefits)Contract Duration: 1 Year (Potential for Extension or Permanent Position)Work Schedule: Full-time, Monday to Friday, 8 AM - 5 PMTCWGlobal is seeking a dedicated Regulatory Affairs Specialist to enhance our team. Our organization is...


  • Fort Worth, United States Actalent Full time

    Regulatory Coordinator II - Hybrid Opportunity Job Description: Looking to hire an individualwith strong regulatory and clinical researchexperienceto act as aRegulatory Coordinator IItosupport an ongoingclinical trials . Please note, as the position and study progress, additional job duties will likely be added that are not listed in this description. A...


  • Fort Worth, United States Randstad Full time

    job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We...

  • Regulatory Affairs

    2 months ago


    Fort Lauderdale, United States 5TH HQ LLC Full time

    Job DescriptionJob DescriptionWe are currently seeking a detail-oriented and motivated Regulatory Affairs Specialist. This role is crucial in ensuring that our products comply with all regulatory requirements. If you are passionate about regulatory affairs and looking for an opportunity to grow within a dynamic company, we encourage you to...


  • Fort Worth, United States Mitchell Martin Full time

    Regulatory Affairs Specialist Fort Worth, TX Contract Not Open For Corp - Corp Only W2 (US Citizen, Green Card, EAD) Job Description: The Associate Director of Regulatory Operations - Labeling will lead and oversee the strategic and operational aspects of regulatory labeling for medical devices. This role is essential in ensuring that all labeling...


  • Fort Worth, United States Mitchell Martin Inc. Full time

    Regulatory Affairs SpecialistFort Worth, TX ContractNot Open For Corp - Corp Only W2 (US Citizen, Green Card, EAD)Job Description:The Associate Director of Regulatory Operations - Labeling will lead and oversee the strategic and operational aspects of regulatory labeling for medical devices. This role is essential in ensuring that all labeling activities...


  • Fort Worth, United States Mitchell Martin Inc. Full time

    Regulatory Affairs SpecialistFort Worth, TX ContractNot Open For Corp - Corp Only W2 (US Citizen, Green Card, EAD)Job Description:The Associate Director of Regulatory Operations - Labeling will lead and oversee the strategic and operational aspects of regulatory labeling for medical devices. This role is essential in ensuring that all labeling activities...


  • Fort Worth, United States Aequor Full time

    Job Title: Regulatory Specialist IIIWork Location: Fort Worth - MainDuration: 6+ MonthsJob Description: The Associate Director of Regulatory Operations - Labeling will lead and oversee the strategic and operational aspects of regulatory labeling for medical devices. This role is essential in ensuring that all labeling activities comply with international...


  • Fort Worth, United States TCWGlobal Full time

    Regulatory Affairs Specialist (R&D/QA)Fort Worth, TX 76104 (*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, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments...


  • Fort Lauderdale, Florida, United States Transpire Bio Full time

    Job Title: Senior Director of Regulatory ComplianceLocation: Weston, FLFunction: Regulatory AffairsReports to: Chief Regulatory Affairs OfficerPosition Overview:The Senior Director of Regulatory Compliance will oversee the strategic planning and execution of regulatory submissions, ensuring adherence to all relevant guidelines and standards. This role is...


  • Fort Worth, United States TalentBurst, an Inc 5000 company Full time

    Position: Associate Director of Regulatory Operations – Labeling // Regulatory Specialist III, Req#: 3048-1Locations: (100% Onsite)Fort Worth, TX Johns Creek, GA Duration: 6+ Months ContractJob Description: Position Purpose:The Associate Director of Regulatory Operations - Labeling will lead and oversee the strategic and operational aspects of regulatory...


  • fort worth, United States TalentBurst, an Inc 5000 company Full time

    Position: Associate Director of Regulatory Operations – Labeling // Regulatory Specialist III, Req#: 3048-1Locations: (100% Onsite)Fort Worth, TX Johns Creek, GA Duration: 6+ Months ContractJob Description: Position Purpose:The Associate Director of Regulatory Operations - Labeling will lead and oversee the strategic and operational aspects of regulatory...


  • Fort Worth, United States TCWGlobal Full time

    Job DescriptionJob DescriptionRegulatory Affairs Specialist (R&D/QA)Fort Worth, TX 76104 (*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-5pmOur client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop...


  • Fort Worth, United States TCWGlobal Full time

    Job DescriptionJob DescriptionRegulatory Affairs Specialist (R&D/QA)Fort Worth, TX 76104 (*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-5pmOur client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop...


  • Fort Lauderdale, Florida, United States 5TH HQ LLC Full time

    Exciting Opportunity: Regulatory Affairs SpecialistA dynamic company, 5TH HQ LLC, is currently seeking a detail-oriented and motivated professional to join their team as a Regulatory Affairs Specialist. This role plays a crucial part in ensuring compliance with regulatory requirements for their products, making it a key position within the organization.Key...


  • Fort Worth, Texas, United States Futures Consulting Full time

    Job OverviewPOSITION: Regulatory Affairs Food SpecialistLOCATION: Fort Worth, TXSHIFT: Monday – Friday onsiteCOMPENSATION: $80-85kKEY RESPONSIBILITIES:Collaborate across departments including operations, quality control, marketing, and sales to ensure compliance with labeling and packaging requirements as well as new product introductions.Evaluate, modify,...


  • Fort Lauderdale, Florida, United States D&H National Research Center Full time

    Job OverviewSalary: $46,000 - $47,500 per yearLanguage Requirement: Spanish (Required)Position SummaryThe D&H National Research Center is seeking a full-time Regulatory Specialist to ensure adherence to regulatory standards and maintain up-to-date knowledge of compliance requirements. This role is essential for the management of regulatory affairs and...


  • Fort Worth, Texas, United States Randstad North America, Inc. Full time

    Join a Leading OrganizationAs a prominent staffing and recruitment agency globally, we are dedicated to connecting you with a role that fosters your professional development in the life sciences sector.Your RoleIn this position, you will be engaged in crucial activities related to regulatory compliance within the healthcare industry. Your expertise will...