- 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, postings, etc.
-
Research Compliance Specialist
1 week ago
University of North Carolina at Charlotte Charlotte, United StatesPosition Information · General Information Position Number Vacancy Open to All Candidates Working Title Research Compliance Specialist Position Designation EHRA Non-Faculty Employment Type Permanent - Full-time Months per Year 12 Work Schedule Monday – Friday, 8:00 am – 5:00 pm ...
-
Research Compliance Specialist
6 days ago
University of North Carolina Charlotte Charlotte, United StatesThis position serves as the Research Compliance Specialist. This position maintains thorough and up-to-date knowledge of relevant federal, state, and university compliance requirements related to research areas. At the direction of the Director of Et Compliance Specialist, Resear ...
-
Research Operations Specialist
2 weeks ago
Integration Appliance, Inc. Charlotte, United StatesLocation: Charlotte, NC office; OR Remote, U.S. Mainland working GMT to Pacific time zone hours, OR UK working GMT to Pacific time zone · At Intapp, we craft and deliver purpose-built AI powered, industry specific solutions to help our customers make better decisions, operate mo ...
-
Administrative Research Specialist
3 weeks ago
Tax Management Associates Charlotte, United StatesJob Description · Job DescriptionTax Management Associates (TMA) is seeking to hire qualified candidates for our Homestead Exemption Audit Program in Charlotte, NC. Homestead Exemption Audit work involves reviewing homestead applications within a state to ensure that the state pr ...
-
Atrium Health Charlotte, United States Full timeOverview · 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/ ...
-
Atrium Health Charlotte, United States Full timeJob 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 guidan ...
-
Field Research Specialist
4 weeks ago
Newell Brands, Inc. Huntersville, United StatesNewell is a leading $10 B global consumer products organization with over 29,000 employees and more than 100 beloved brands. Newell's vision is to become a consumer led, innovation powerhouse and growth engine that is a force for good and an amazing Research, Specialist, Field, P ...
-
Office Assistant/Research Specialist
7 hours ago
Winthrop University Rock Hill, United StatesPosting Details · Position Information · Winthrop Position Title · Office Assistant/Research Specialist (FWS) · Job Purpose · Assist with the research and data entry needs of the alumni and donor database. · Duties and Responsibilities · Assist with data research, data entry, ...
-
Civil Engineer
1 week ago
Atlas Ventures Gastonia, United StatesYour Contribution · You will independently work on projects for public clients and coordinate your project team · You will be responsible for structural engineering and water engineering for construction projects · You will create tender documents (construction descriptions, perf ...
-
Levine Cancer Institute Medical Director
2 weeks ago
Atrium Health Charlotte, United StatesOverview · If its possible, you will find it at Atrium Healththe leading community-focused academic healthcare system serving North Carolina, South Carolina, and Georgia. We invite · Hematology/Oncology physicians · to discover all that we can do when we bring healing hearts, inq ...
-
Atrium Health Charlotte, United States Full timeOverview · Job Summary · 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. · Essential Functions ...
-
Meteorologist/Climate Specialist
1 week ago
Nexstar Media Group Charlotte, United States Full timeWe are looking for a Meteorologist/Climate Specialist to be responsible for studying weather patterns and what causes them. The responsibilities of this position include making predictions on weather changes for the long-term, researching causes of weather changes, and analyzing ...
-
National Center for Families Learning Charlotte, United StatesThe National Center for Families Learning, a private nonprofit organization located in Louisville, KY, is seeking a Content Specialist, Family Literacy to provide subject matter expertise on trends and issues involving family literacy. The Content Specialist, Family Literacy will ...
-
Regional Sales Manager
3 weeks ago
CSL Seqirus Charlotte, United StatesThe Opportunity: · Join a company that tackles fascinating problems and find solutions to complex challenges. With expertise in influenza science and beyond, our team works on the latest research, pioneering technologies to improve the manufacturing process and improve the effect ...
-
Atrium Health Charlotte, United StatesOverview · If its possible, you will find it at Atrium Healththe leading community-focused academic healthcare system serving North Carolina and South Carolina. We invite Psychologists to discover all that we can do when we bring healing hearts, inquisitive minds, and progressive ...
-
Accounts Receivable Collections Specialist
2 weeks ago
TEKsystems Charlotte, United States Contract to RegularWe are looking to add an Accounts Receivable/Collections specialist to the team in Charlotte, NC on a 6 month CTH. This person will be working 8:00-4:30 with a 30 minute lunch 5 days a week, Monday-Friday. This role would be responsible for daily research, calls & customer intera ...
-
Fraud Specialist
2 weeks ago
AccruePartners Charlotte, United StatesTHE TEAM YOU WILL BE JOINING: · Dynamic and creative company located in Charlotte, NC, and Headquartered in San Francisco. · Dedicated to making financial progress possible for everyone. · National presence providing excellent service to over 60 million members. · Vibrant work en ...
-
University of North Carolina at Charlotte Charlotte, United StatesPosition Information · General Information Position Number Vacancy Open to All Candidates Working Title Senior Financial and Subrecipient Compliance Specialist Position Designation EHRA Non-Faculty Employment Type Permanent - Full-time Months per Year 12 Work Schedule 8:00am – 5 ...
-
Ad Operations Specialist
3 weeks ago
Spectrum Reach Charlotte, United StatesSpectrum Reach ) grows businesses of all sizes with custom, multiscreen advertising solutions, backed by the power of TV, data, innovation, community experts, and unforgettable creative. · At A Glance... · Our Ad Operations Specialist are centralized roles that support the entire ...
-
Recruitment Support Specialist
3 weeks ago
Partners Personnel Charlotte, United StatesWe are looking for a driven, self-motivated, bilingual (Spanish/English) Recruiting Support Specialist to join team · Experienced in high volume recruiting? We are looking for go-getters with high energy who are creative, super organized and detail oriented, and are self-driven t ...
Phase 1 Registered Nurse Oncology Research Specialist - Charlotte, NC, United States - Atrium Health
![Atrium Health background](https://contents.bebee.com/companies/us/atrium-health/background-QcqyS.png)
Description
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.
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 CertificationsMust 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.