locations
Charlotte, NC - 1021 Morehead Medical Dr
time type
Full time
posted on
Posted Today
job requisition id
R165661
Department:
80096 Carolinas Medical Center - LC: Clinical Trials: Morehead
Status:
Full time
Benefits Eligible:
Yes
Hours Per Week:
40
Schedule Details/Additional Information:
This position is Sign-on Bonus eligible. Based on eligibility.
Job Summary
Assists with the coordination of clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted by the Levine Cancer Institute, following industry standards and applicable regulations including FDA/OHRP guidances, GCP and ICH.
Essential Functions
Assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within LCI.
Participates in the study project start-up activity, working with the PI and others to initiate new research projects.
Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assuring all documentation is managed compliantly and maintained in an audit-ready manner.
Maintains appropriate documentation, (i.e. FDA Form 1572, CTSU documentation, IRB approval letters, ICFs, etc.) for assigned studies.
Assists in maintenance of filing systems, data repositories and systems.
Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately.
Obtains required documentation (forms, slides, reports, etc.) to assess patient eligibility for research studies.
Contacts local research staff to confirm scheduling of tests/treatments required by protocol.
Obtains and completes data for patients enrolled on clinical trial.
Completes Case Report Forms (CRFs) maintaining high level of accuracy.
Completes/resolves queries from sponsors.
Obtains required forms, slides, reports, and other information needed to assess patient eligibility.
Prepares and submits information from patient's chart and other source documents on appropriate data forms/flowsheets/databases.
Assists with inventory, ordering, organization and distribution of supplies related to assigned trials.
Maintains supply inventory with critical focus on expiry management.
Maintains regulatory binder for review at monitoring visits.
Maintains patient shadow charts with appropriate source documentation.
Completes registration for patient enrollment and maintains status in sponsor and LCI databases.
Assists with the coordination of research monitor visits and audits; prepares appropriate data.
Assists in the collection, preparation and shipping of samples.
Assists with the coordination of required protocol-related activities such as tests and treatments using CTMS.
Assists in writing/updating Informed Consents with PI and team.
Supports the clinical trial team to efficiently complete tasks including documentation/submissions, Serious Adverse Events (SAEs)/safety reports, FDA Form 1572, DARFs, ClinicalTrials.gov postings, etc.
Physical Requirements
Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.
Education, Experience and Certifications
Must hold a valid North Carolina or South Carolina (as applicable) Board of Nursing license. Graduate of an accredited nursing program (ADN, RN) required. Bachelor's Degree in Nursing (BSN), or higher, preferred. CPR certification required. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.
Pay Range
$37.50 - $56.25
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
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.