Job Req ID: 185226
Position Number: 00166734
Employment Type: Full Time
Shift: Variable/On Call
Shift Details: M-F, Days/Variable
Standard Hours: 40.00
Department Name: LCI Clinical Trials
Location: Carolinas Medical Center
Location Details: Levine Cancer Institute, Main, 28203
Carolinas HealthCare System is Atrium Health. Our mission remains the same: to improve health, elevate hope and advance healing - for all. The name Atrium Health allows us to grow beyond our current walls and geographical borders to impact as many lives as possible and deliver solutions that help communities thrive. For more information, please visit carolinashealthcare.org/AtriumHealth
Coordinates the clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH for investigator-initiated research (IIR) studies at Levine Cancer Institute. Works under the guidance of the IIR Project Manager (PM), in the sponsor role of maintaining oversight of LCI's Investigator-initiated research studies.
- Fulfills the job responsibilities of the Oncology Research Specialist, and:
- Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination and other reportable regulatory information.
- Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, monitor and other internal/external customers; coordinates documentation/submissions. Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
- Collects, records and relays SAEs to appropriate parties (funders, regulatory / FDA, etc.) in collaboration with IIR PM
- Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance and ensures timely and accurate submission of data.
- Coordinates and prepares for internal and external audits.
- Participates in sponsor study start-up and follow-up meetings as appropriate.
- Develops study calendars.
- Collaborates on billing and financial activity with Research Finance (budgets and billing compliance).
- Coordinates scheduling of patient visits, labs, and diagnostic procedures.
- Coordinates drug shipments, storage, and accountability with IDS/Pharmacy.
- Assists in the development, improvement and review of Standard Operating Procedures and processes.
- Provides educational and technical assistance to research staff including orientation and mentoring of new research teammates.
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
Bachelor's Degree and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Health/Science degree preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.
At Atrium Health, formerly Carolinas HealthCare System, our patients, communities and teammates are at the center of everything we do. Our commitment to diversity and inclusion allows us to deliver care that is superior in quality and compassion across our network of more than 900 care locations.
As a leading, innovative health system, we promote an environment where differences are valued and integrated into our workforce. Our culture of inclusion and cultural competence allows us to achieve our goals and deliver the best possible experience to patients and the communities we serve.
Posting Notes: Not Applicable
Carolinas HealthCare System is an EOE/AA Employer
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