Clinical Research Regulatory Specialist

2 weeks ago

Irvine, California, United States University Of California Irvine Full time

Overview:

Established in 1965, University of California, Irvine is a distinguished member of the Association of American Universities, consistently ranked among the top public universities in the nation. The institution is recognized for its academic excellence, innovative research, and vibrant campus life. With over 36,000 students and a wide array of degree programs, UC Irvine plays a significant role in the local economy, contributing billions annually.

The Chao Family Comprehensive Cancer Center (CFCCC) at UC Irvine is a collaborative organization dedicated to advancing cancer research and patient care. With a multidisciplinary approach, the CFCCC supports approximately 175 members in their research endeavors and provides comprehensive cancer care.

Key Responsibilities:

As a Clinical Research Regulatory Specialist, you will work under the guidance of the Regulatory Program Manager (RPM) within the Regulatory Affairs Unit. Your primary role will be to facilitate the clinical research initiatives of the CFCCC by ensuring meticulous regulatory oversight of cancer-related studies in compliance with federal regulations, internal procedures, and university policies.

Your responsibilities will include:

  • Independently managing and preparing submissions for new studies, modifications, renewals, adverse events, and study closures to relevant regulatory bodies.
  • Effectively navigating protocols through the regulatory committee process to ensure timely activation of trials.
  • Acting as a liaison to sponsors and regulatory agencies, ensuring clear communication and documentation.
  • Maintaining accurate regulatory information within the clinical trial management system and adhering to institutional policies.

Qualifications:

Required:

  • Strong interpersonal skills to engage with diverse stakeholders.
  • Proficient in organizing and maintaining comprehensive records.
  • Ability to collaborate effectively within an interdisciplinary team.
  • Exceptional communication skills for clear and concise information dissemination.
  • Proven problem-solving abilities to address unexpected challenges.
  • Experience in conducting thorough research and preparing organized reports.
  • Capacity to prioritize a dynamic workload and meet deadlines.
  • Demonstrated initiative and sound judgment in decision-making.
  • Ability to work independently and as part of a team.
  • High attention to detail and integrity in maintaining confidentiality.
  • Familiarity with Microsoft Office Suite.
  • 3 to 5 years of relevant experience in a coordination role, preferably with a Bachelor’s degree.
  • Experience with submissions to institutional research committees.

Preferred:

  • Knowledge of various human subject clinical trials.
  • Experience with clinical trial management systems.
  • Background in cancer-related research.

Special Conditions:

  • Access to transportation for off-site research locations.
  • Potential for study management coordination outside of standard business hours.
  • Willingness to travel to satellite sites as necessary.

Compensation and Benefits:

UC Irvine offers a competitive salary and a comprehensive benefits package, including medical insurance, retirement savings plans, and various employee perks.

Conditions of Employment:

All candidates must comply with the university's employment conditions, including background checks and adherence to vaccination policies.

Closing Statement:

UC Irvine is an Equal Opportunity/Affirmative Action Employer, committed to fostering a diverse workforce and inclusive environment.

  • Clinical Research Regulatory Specialist

    2 weeks ago

    Irvine, California, United States University Of California Irvine Full time

    Overview:Established in 1965, University of California, Irvine is recognized as a leading institution in the Association of American Universities and consistently ranks among the top public universities in the nation. With a vibrant community of over 36,000 students and a diverse array of 224 degree programs, UC Irvine is dedicated to academic excellence and...

  • Senior Regulatory Affairs Specialist, Critical Care

    2 weeks ago

    Irvine, California, United States Regulatory Affairs Professionals Society Full time

    Join Our Team as a Senior Regulatory Affairs Specialist in Critical CareFor over five decades, the Critical Care division at Regulatory Affairs Professionals Society has been at the forefront of pioneering medical advancements and enhancing patient care. Our mission is clear: we strive to ensure that every patient requiring monitoring has access to...

  • Lead Specialist in Regulatory Affairs for Critical Care

    2 weeks ago

    Irvine, California, United States Regulatory Affairs Professionals Society Full time

    Join Our Team:At Regulatory Affairs Professionals Society, we are dedicated to advancing the field of regulatory affairs, particularly within the Critical Care sector. Our mission is to ensure that every patient receives the highest standard of care through innovative medical technologies.Your Role:As a Senior Regulatory Affairs Specialist, you will play a...

  • Sr. Clinical Research Specialist

    1 month ago

    Irvine, California, United States Johnson & Johnson Full time

    Mentor Corporation, a member of the Johnson & Johnson Family of Companies, is currently recruiting a Sr. Clinical Research Specialist located in Irvine, CA.*There is already an identified candidate for the role.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are...

  • Clinical Research Associate

    2 weeks ago

    Irvine, California, United States Cynet Systems Full time

    Job OverviewWe are seeking a Clinical Research Associate to support our client in their clinical research initiatives.Position Title: Clinical Research AssociateLocation: RemoteEmployment Type: ContractCompensation: $38.56/hr - $43.56/hrKey Responsibilities:Assist in the evaluation and upkeep of study and site documentation, aiding in the management of...

  • Regulatory Affairs Senior Consultant, Critical Care

    2 weeks ago

    Irvine, California, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full time

    Regulatory Affairs Senior Consultant, Critical CareCompany: Orange County Regulatory Affairs Discussion Group (OCRA)Position: Senior Regulatory Affairs SpecialistLocation: Remote/HybridOverview: Join a team dedicated to enhancing patient outcomes through innovative regulatory strategies. As a Senior Consultant in Regulatory Affairs, you will play a pivotal...

  • Regulatory Compliance Specialist

    2 weeks ago

    Irvine, California, United States Jobot Full time

    Join a Leading Medical Device Company as a Regulatory Affairs SpecialistAbout the Role:We are seeking a talented and experienced Regulatory Affairs Specialist to become a vital part of our team within the medical device sector. This role is essential in maintaining our compliance with various domestic and international regulations, guidelines, and...

  • Senior Clinical Research Manager

    2 weeks ago

    Irvine, California, United States Actalent Full time

    Position Title: Senior Clinical Research ManagerWe are in search of a Senior Clinical Research Manager to lead the strategic operational oversight of both pre-market and post-market clinical trials.This position emphasizes the improvement of effective execution in review and approval workflows, contract negotiations, and communication with clinical study...

  • Regulatory Operations Specialist

    9 hours ago

    Irvine, California, United States Entegee Full time

    Job OverviewEntegee is seeking a highly skilled Regulatory Operations Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in the US and EU markets.Key ResponsibilitiesManage submission content and publishing for US and EU marketsRegulate master...

  • Regulatory Affairs Specialist

    9 hours ago

    Irvine, California, United States Brett Fisher Group Full time

    Job DescriptionAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Brett Fisher Group. As a key member of our organization, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory strategies to support the...

  • Regulatory Compliance Specialist

    2 weeks ago

    Irvine, California, United States Inari Medical Full time

    The Regulatory Affairs Specialist operates with a high degree of autonomy, providing essential support to multidisciplinary teams in the formulation and implementation of regulatory strategies for innovative devices and modifications.Key Responsibilities Act as the regulatory liaison for cross-functional project teams.Develop and implement regulatory...

  • Regulatory Compliance Specialist

    1 week ago

    Irvine, California, United States Brett Fisher Group - Search Consultants Full time

    Why Consider This Opportunity? Our client, a prominent manufacturer and distributor in the medical device sector, specializes in anesthesia and respiratory solutions. They are recognized for their commitment to innovation, consistently acquiring, licensing, and launching new products globally. With a presence in over 105 countries and operations across 12...

  • Regulatory Compliance Specialist

    2 weeks ago

    Irvine, California, United States Insight Global Full time

    Essential Qualifications:Bachelor's Degree in a relevant fieldMinimum of 2 years' experience in regulatory compliance or complaint managementProven track record in managing the complete process of complaint resolution (initiation, investigation, and closure)Experience in preparing and submitting documentation to the FDAFamiliarity with Good Manufacturing...

  • Clinical Research Nursing Operations Manager

    2 weeks ago

    Irvine, California, United States University Of California Irvine Full time

    About Us Established in 1965, University of California, Irvine is a distinguished member of the Association of American Universities, consistently ranked among the top public universities in the nation. With a legacy of academic excellence and innovation, UC Irvine is home to numerous Nobel laureates and is recognized for its vibrant research community. The...

  • Nutritional Regulatory Affairs Expert

    2 weeks ago

    Irvine, California, United States Arbonne Full time

    Position Overview:The role of Nutrition Compliance Specialist at Arbonne involves reporting to the Senior Manager and collaborating closely with Research & Development and Marketing teams. This position is pivotal in ensuring that nutritional products adhere to regulatory standards in various markets where Arbonne operates. Responsibilities include...

  • Clinical Research Caregiver

    2 weeks ago

    Irvine, California, United States University Of California Irvine Full time

    About Us Established in 1965, University of California Irvine is a distinguished member of the Association of American Universities, consistently ranked among the top public universities in the nation. Our campus has produced five Nobel laureates and is recognized for its commitment to academic excellence, groundbreaking research, and innovation. With over...

  • Lead Regulatory Affairs Consultant

    2 weeks ago

    Irvine, California, United States myTOD, LLC Full time

    Senior Compliance Specialist in Regulatory AffairsAbout myTOD, LLC:myTOD, LLC is at the forefront of Smart Technology, committed to revolutionizing the medical device sector with pioneering solutions that improve patient outcomes. Our advanced products are crafted to adhere to the highest standards of quality and regulatory adherence. As an expanding...

  • Medical Content Specialist

    2 days ago

    Irvine, California, United States PRISMATIK DENTALCRAFT, INC. Full time

    Job SummaryPRISMATIK DENTALCRAFT, INC. is seeking a highly skilled Medical Content Specialist to join our team. As a Medical Content Specialist, you will be responsible for researching, compiling, and editing subject matter related to the dental industry.Key ResponsibilitiesResearch and Content Development: Conduct research using PubMed, Google Scholar, and...

  • Regulatory Affairs Consultant

    2 weeks ago

    Irvine, California, United States Jobot Full time

    Join a reputable medical device organization as a Regulatory Affairs SpecialistThis opportunity is hosted by Jobot.Compensation: $80,000 - $95,000 annuallyAbout Us:We are a leading manufacturer in the medical device sector, seeking a Regulatory Affairs Specialist to enhance our team. Candidates with experience in Class II/III medical devices are encouraged...

  • Lead Clinical Research Scientist

    2 weeks ago

    Irvine, California, United States Kelly Science, Engineering, Technology & Telecom Full time

    Senior Research Scientist in Clinical DevelopmentPosition Overview:This role involves a hybrid work model, providing flexibility while contributing to significant clinical projects.Qualifications:A Bachelor's degree in a relevant field is essential, accompanied by a minimum of 5 years of experience in clinical research.Preferred candidates will possess an...