14 days old

Research Regulatory Manager - Telecommute - 934758

El Segundo, CA 90245 Work Remotely
Apply Now
Apply on the Company Site
  • Job Code
    934758

Optum is a company that's on the rise. We're expanding in multiple directions, across borders and, most of all, in the way we think. Here, innovation isn't about another gadget, it's about transforming the health care industry. Ready to make a difference? Make yourself at home with us and start doing your life's best work.(sm)

""

In support of the quadruple aim and Optum Cares mission, the Center for Research and Innovation (OCRI) Regulatory Manager will work integrally with the research teams and serves as the regulatory subject-matter resource. The Manager will report to the OCRI Executive Director and acts as a liaison between OCRI, industry sponsors and the various research sites and IRBs that Optum Care partners with, secures IRB approval for new research studies, and ensures effective and timely reporting and exchange of regulatory correspondence and metrics related to the multitude of research studies performed by our Care Delivery Organizations (CDOs). Dependent upon interest, experience, and need, the Specialist may also have growth/development opportunities such as oversight of additional research staff, quality monitoring or contributing to research education and training.

""

Youll enjoy the flexibility to telecommute* from anywhere within the U.S. as you take on some tough challenges.

""

Primary Responsibilities:

""
    ""
  • Serves as an expert resource to research study staff and investigators in the interpretation and application of IRB requirements, the Health Insurance Portability and Accountability Act (HIPAA), Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs)
  • ""
  • Provides regulatory assistance to the research teams by collecting, preparing, editing and study related documents which may include: IRB applications, consent forms, reports and correspondence for Enterprise level projects
  • ""
  • Implements, updates and maintains CTMS system and assist research sites with essential documentation on all studies under OCRIs purview
  • ""
  • Communicates regularly with research study staff, sponsors, IRBs and other stakeholders regarding the status of startup and ongoing regulatory duties
  • ""
  • Works collaboratively with OCRI leadership and employees as part of a positive, supportive culture
  • ""
  • Provides Leadership with routine metrics, analysis and reporting related to regulatory and compliance functions and works collaboratively on potential solutions to address concerns or areas of potential risk
  • ""
  • Leads efforts to assess potential expansion of regulatory staff role and assists in development, change management around and implementation of any expansion
  • ""
  • Scans, evaluates and translate for implementation changes in applicable laws, regulations, guidance, Federal agency expectations and national practice standards
  • ""
  • Creates and improves upon SOPs, guidelines, tools, and processes to support high-quality IRB and regulatory work and general research compliance
  • ""
  • Develops and executes a regulatory monitoring and auditing process to ensure compliance with applicable internal, federal and state regulations
  • ""
  • Delivers routine educational and training content to research staff on an as-needed basis
  • ""
  • With Program Manager, develops and implements robust, multi-faceted internal quality monitoring program, to include creation of tools, strategic plan and routine metrics and reporting
  • ""
  • Other opportunities for significant, high-level contribution may be available dependent upon candidate interest and experience and program need
  • "
""

""

Youll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

"

Required Qualifications:

""
    ""
  • Bachelors degree and/or 4+ years of experience in research
  • ""
  • 3+ years of experience in clinical research with a deep understanding of regulatory document requirements
  • ""
  • Working knowledge of applicable FDA, IRB and HIPAA regulations and guidance, ICH GCP standards, etc.
  • ""
  • Experience working with others as a team and in support of a positive work culture across enterprise and cross-functional
  • "
""

Preferred Qualifications:

""
    ""
  • Certification in clinical research, IRB, or healthcare compliance (including but not limited to CCRA, CCRC, ACRP-CP, or CIP)
  • ""
  • Experience auditing or monitoring research
  • ""
  • Ability to think critically, exercise sound independent judgment, adapt to an evolving internal and external regulatory environment, and manage competing priorities
  • ""
  • Ability to recognize problems or situations that are new or do not have clear precedent; evaluates alternatives and finds solutions that fall within applicable policies and regulations
  • "
""

""

""

Careers with Optum. Here's the idea. We built an entire organization around one giant objective; make health care work better for everyone. So when it comes to how we use the world's large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life's best work.(sm)

""

""

OptumCare is committed to creating an environment where physicians focus on what they do best: care for their patients. To do so, OptumCare provides administrative and business support services to both owned and affiliated medical practices which are part of OptumCare. Each medical practice part and their physician employees have complete authority with regards to all medical decision-making and patient care. OptumCares support services do not interfere with or control the practice of medicine by the medical practices or any of their physicians.

""

""

*All Telecommuters will be required to adhere to UnitedHealth Groups Telecommuter Policy.

""

""

Colorado Residents Only: The salary range for Colorado residents is $64,800 to $116,000. Pay is based on several factors including but not limited to education, work experience, certifications, etc. In addition to your salary, UnitedHealth Group offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with UnitedHealth Group, youll find a far-reaching choice of benefits and incentives

""

""

Diversity creates a healthier atmosphere: OptumCare is an Equal Employment Opportunity/Affirmative Action employers and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.

""

""

OptumCare is a drug-free workplace. Candidates are required to pass a drug test before beginning employment

""

""

""

""

Job Keywords: Research Manager, Research Associate, Consultant, Compliance, Program Manager, IRB, International Review Board, CTMS implementation, regulation, auditing, Telecommute, Remote, Work from Home

Posted: 2021-07-10 Expires: 2021-08-09

UnitedHealth Group is the most diversified health care company in the United States and a leader worldwide in helping people live healthier lives and helping to make the health system work better for everyone.

Sponsored by:
ADP Logo

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Research Regulatory Manager - Telecommute - 934758

UnitedHealth Group
El Segundo, CA 90245

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast