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
Job Summary Coordinates the 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.
Competently 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.
Assesses patient eligibility through chart reviews and patient/family interviews.
Assists in providing patient education regarding the nature of their disease and the benefits/risks of participating in a clinical drug trial.
Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor and other internal/external customers to efficiently coordinate documentation/submissions. Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
Presents and obtains patient informed consent.
Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance.
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 across LCI locations.
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 staff.
Collaborates and participates with teams across the LCI enterprise in a professional and courteous manner.
Interacts professionally with patients and families.
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. Bachelors Degree (BS) and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Masters Degree (MS) 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. Bachelors Degree in Nursing (BSN) or Masters Degree in Nursing (MSN) or other health/science degree concentration 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.
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 Associated topics: asn, care, care unit, infusion, intensive care, intensive care unit, maternal, surgical, tcu, transitional
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.