11 days old

Clinical Research Regulatory and Data Coordinator - Multiple Locations - 931743

Arlington, TX 76010
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  • Job Code
    931743

Do you have compassion and a passion to help others? Transforming healthcare and millions of lives as a result starts with the values you embrace and the passion you bring to achieve your lifes best work.(sm)

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The Clinical Research Regulatory and Data Coordinator, under the guidance and supervision of the Principal Investigator (PI) and (Insert Director of Research Operations or other job title here) ensures the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and (Insert name of the practice or business) policies and procedures. This position is also responsible to ensure completeness, accuracy and compliance with each protocol from the standpoint the Principal Investigator regulatory and data obligations in working collaboratively with the Clinical Research Nurse.

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Primary Responsibilities:

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  • Ensuring assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and Good Clinical Practices (GCP) guidelines:"""
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    • Reviews and comprehends the protocol. Assists the Clinical Research Nurse in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training
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    • Collaborates with the PI to prepare IRB and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested. These study materials include but are not limited to the informed consent document, source documents, enrollment logs, and drug / device accountability logs
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    • Ensures site compliance with research protocols by reviewing all regulatory and data requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
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    • Supports the Clinical Research Nurse in the development of accurate source materials and ensures compliance from site staff
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    • Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and OCRI databases / Clinical Trial Management System (CTMS)
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    • Establishes and organizes study files, including but not limited to, regulatory binders, case report and study specific forms
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    • Other duties as assigned
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  • Other:""
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    • Participates with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
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    • Occasional travel to attend sponsor study training meetings, as required
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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.

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Required Qualifications:

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  • Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures
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  • This position requires Tuberculosis screening as well as proof of immunity to Measles, Mumps, Rubella, Varicella, Tetanus, Diphtheria, and Pertussis through lab confirmation of immunity, documented evidence of vaccination, or a doctor's diagnosis of disease
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  • If you need to enter a work site for any reason, you will be required to screen for symptoms using the ProtectWell mobile app, Interactive Voice Response (i.e., entering your symptoms via phone system) or similar UnitedHealth Group-approved symptom screener. When in a UnitedHealth Group building, employees are required to wear a mask in common areas. In addition, employees must comply with any state and local masking orders
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Preferred Qualifications:

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  • Clinical Research Certification
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  • 2+ years of oncology clinical trials research experience
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Careers with WellMed. Our focus is simple. We're innovators in preventative health care, striving to change the face of health care for seniors. We're impacting 550,000+ lives, primarily Medicare eligible seniors in Texas and Florida, through primary and multi-specialty clinics, and contracted medical management services. We've joined Optum, part of the UnitedHealth Group family of companies, and our mission is to help the sick become well and to help patients understand and control their health in a lifelong effort at wellness. Our providers and staff are selected for their dedication and focus on preventative, proactive care. For you, that means one incredible team and a singular opportunity to do your life's best work.(sm)

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WellMed was founded in 1990 with a vision of being a physician-led company that could change the face of healthcare delivery for seniors. Through the WellMed Care Model, we specialize in helping our patients stay healthy by providing the care they need from doctors who care about them. We partner with multiple Medicare Advantage health plans in Texas and Florida and look forward to continuing growth.

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Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer 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.

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

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Job Keywords: Clinical Research, Clinical Research Analyst, Clinical Research Specialist, Clinical Data Analyst, Regulatory, Data, Arlington, Hurst, Irving, Fort Worth, North Richland Hills, Euless, Grapevine, Mansfield, Grand Prairie, TX, Texas

Posted: 2021-06-03 Expires: 2021-07-03

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.

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Clinical Research Regulatory and Data Coordinator - Multiple Locations - 931743

UnitedHealth Group
Arlington, TX 76010

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