LCI Oncology Research Consultant - RN
Charlotte, NC, United States
Job ID: 68790
Job Family: Nursing
Status: Full Time
Detailed Shift and Schedule: M-F 8am - 5pm
Remote Opportunity: Yes
Job Type: Regular
Department Name: 11011036640304-Clinical Trials - LCI
Conducts and develops all aspects of clinical, regulatory, business, and other research- related activities and documentation for clinical trials on behalf of the Levine Cancer Institute, following industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.
- Becomes familiar with the Epic treatment plan build process
- Is the Epic treatment plan intake form specialist who completes necessary information per protocol
- Liaison between all the stakeholders (IAS treatment plan builders, Study Start-Up (SSU) team, Investigational Drugs Services (IDS), Budget Specialists & Contract Specialists)
- Pulls adverse event (AE) information per protocol needed for AE template builds
- Is the Superuser point of contact for teammates, familiar with all the things: linking, applying treatment plans, notes, etc.
- Teaches Epic treatment plan related tasks at lunch and learns, team huddles, etc. and trains new teammates as part of the Epic treatment plan cohort
- Checks Epic to ensure teammates are performing the linking and application of treatment plans and notes
- May assist MDs and clinics with best practices and changes
- Competently fulfills the job responsibilities of the Oncology Research Coordinator, and:
- Assists Principal Investigator and team in evaluating feasibility of research studies.
- Develops study budget in collaboration with team.
- Coordinates documentation for regulatory requirements.
- Coordinates trial-related activity of patients on protocols.
- Coordinates, follows, and evaluates patient participation in clinical trials to ensure compliance with the protocol.
- Coordinates protocol-specific clinical tasks including patient assessment, eligibility screening, symptom management, toxicity assessment, and monitoring of responses.
- Coordinates protocol-specific scheduling of tests and specimen collection across LCI locations.
- Monitors and reports significant study events including adverse events and protocol amendments, activity, status, and closures.
- Performs required study procedures, collects data, analyzes data and makes decisions regarding the clinical research study conduct, including initial screening, assessment, care, reassessment and modification of care in consultation with PI and team.
- Assists in data analysis and drafting of clinical study reports.
- Develops, updates and/or implements standard operating procedures (SOPs).
- Serves as a team leader.
- Serves as the key resource for Principal Investigator, physicians and research team and acts as the primary liaison with sponsors to facilitate study initiation, execution and termination.
- Ensures accurate and timely data collection, submission, and query resolution.
- Coordinates protocol-level documentation to ensure regulatory and institutional compliance.
- Educates patients and families about research studies, treatments, side effects and follow-up, as appropriate.
- Coordinates protocol activities across Levine Cancer Institute.
- Collaborates with investigators through attendance at Section meetings, conferences, and other meetings.
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. Bachelor's Degree and 3 years of clinical research experience with a pharmaceutical company or Contract Research Organization or equivalent experience required; or Master's Degree and 2 years of clinical research experience with a pharmaceutical company or Contract Research Organization or equivalent experience required; or a minimum of 6 years clinical research experience with a pharmaceutical company or Contract Research Organization or equivalent experience required with no degree. Bachelor's Degree in Nursing or Master's Degree in Nursing 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. Supervisory experience preferred.