Department:
37294 Carolinas Medical Center - LC: Biostatistics and Data Sciences: Morehead
Status:
Full time
Benefits Eligible:
Yes
Hours Per Week:
40
Schedule Details/Additional Information:
Remote, Full Time, Business Hours
Pay Range
$35.50 - $53.25
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M-F, day shift, 8 hours per day with some flexibility in hours
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This position is fully remote with the possibility of infrequent travel.
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The ideal applicant would have a bachelor’s degree with clinical research experience, including oncology experience and/or experience monitoring clinical research studies and/or conducting audits of studies.
- In addition to experience at a contract research organization (for example - PPD, ICON, Parexel, IQVIA Clinical Research Experience) or pharmaceutical company (Merck, Bristol-Myers Squibb, Astra Zeneca, Novartis, Johnson and Johnson), working at a site level as a research data manager, clinical research coordinator, clinical research assistant, research project manager have more transferrable experience than solely work in research labs.
Essential Functions
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Work both independently and as part of a sponsor team commensurate with responsibilities of an Industry/CRO Clinical Trials level II monitor
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Handle several priorities within multiple, complex trials
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Perform site selection, interim and close-out monitoring visits
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Manage studies to ensure adherence to protocol, GCP and regulations, ensuring patient safety, and well-being, as well as verifying accuracy of clinical trial data with minimal oversight from mentors/QA manager
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Review study drug storage, stability, inventory, and accountability. Verify destruction of unused product as required
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Perform essential Site Regulatory File review and reconciliation.
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Communicate findings in a timely manner to all sites per timelines defined in LCI QA SOPs and guidelines. Set-up meetings, when necessary, to communicate concerns/findings to the site PI/SI
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Develop Protocol Specific Monitoring Plans
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Independently collaborate with research sites to prepare site for Co-operative Group audits and/or FDA Inspections
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Conduct training/presentations to Clinical Trials Site on Quality Assurance and site expectations
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Participate in Protocol and eCRF development
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Participate in developing and updating LCI QA SOPs, guidelines and processes
Physical Requirements
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Primarily works in an office setting
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Requires full range of body motion; sitting for extensive periods of time; walking; standing, reading, and writing/keyboarding
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Occasionally lifts and carries items weighing up to 35 pounds
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Requires corrected vision and hearing within normal range
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Must speak and read/write clearly in English
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Must be able to be mobile within the entire healthcare system and external locations that participate in LCI clinical trials. Some of these locations maybe out of state.
Education, Experience and Certifications
Excellent written and verbal skills as well as excellent organizational and interpersonal skills. Be familiar with current Good Clinical practices and the Code of Federal Regulations. A Bachelor's degree in a healthcare or other scientific discipline required. At least 4 years' experience in clinical research at a pharmaceutical company or a Contract Research Organization (CRO) required with at least 2 years auditing / monitoring experience preferred. Alternatively, an equivalent combination of education, training and experience will be considered. Relevant certification (ACRP, SoCRA, Risk Based Quality Management or equivalent) preferred.
Our Commitment to You:
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:
Compensation
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance
Benefits and more
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.
About Advocate Health
Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
Assist with the compilation of required documents for trial activation. Manage studies to ensure adherence to protocol, Good Clinical Practice (GCP) and regulations, ensuring patient safety, and well-being as well as verifying accuracy of clinical trial data with minimal oversight from mentors/QA manager. Assist in training of research staff. Analyze supplies, procedures, and processes of trials at medical sites and suggest options as needed. Monitor informed consent and eligibility processes.
