Company: State Of North Carolina
Location: Chapel Hill
Posted on: September 16, 2021
- Implementation of oncology clinical research requires planning
and teamwork in order to assure patient safety and research
- Coordinates multiple complex trials through the protocol life
cycles of activation, implementation and closure.
- Knowledge of both GCP and full knowledge of individual research
- Independently plan, organize, and evaluate implementation of
multiple oncology clinical research projects with knowledge of, and
in compliance with, sponsor requirements.
- Knowledge of research protocol and related documents, plan and
document methodologies for research subject and data management
based on this knowledge.
- Ability to train others in research methodology and direct the
work of team members and staff from other services to complete
- Serve as content expert for multiple, complex trials; instructing
other members of research team as well as staff from other services
which interface in conducting oncology clinical research
- Establish communication systems and lead conversations to ensure
complete execution of all aspects of trial conduct. Develop tools
to gather required data and to facilitate compliant conduct of
clinical research; educate team on procedures.
- Facilitate meetings between sponsors, investigators, and research
team to assess feasibility and design of the protocol. Attend
Investigators Meetings and teach others based on knowledge
obtained. Lead start-up meetings and other on-site with the
Protocol Office research team, Principal Investigator and auxiliary
departments when their services are required; instruct team in
coordinative aspects of the protocol and conduct training across
- Education patients about participating in a research study to
ensure patient safety and improve protocol compliance
- Create Subject Management Plan for multiple oncology clinical
trials and direct implementation. - Based on knowledge of GCP and
research protocols, identify and modify research methodologies to
meet research objectives as they relate to subject interface with
research process. Document plan for each trial, including
procedures for quality control.
- Recruitment, Screening, Eligibility, and Registration of Research
Subjects. Eligibility assessment of oncology patients requires both
full knowledge of research regulations and strict adherence to
individual trial procedures.
- Study Coordinators are expected to conduct this aspect of
clinical research in close communication with the Principal
- Study Coordinators are responsible for multiple trials and
accountable to multiple investigators.
o Manage Quality Control process of securing documentation of each
eligibility criterion (typically 30 different criteria for each
research protocol) and overseeing verification by peer staff member
and Principal Investigator.
o Responsibility for managing eligibility process to full execution
Identification and screening of potential subjects according to
procedures for CPO and Sponsor and Subject Management Plan,
Obtaining consent from eligible patients in compliance with
applicable regulations and prior to any study related
Determining patient eligibility by examining and analyzing the
results of the tests and medical records.
Register patients in OnCore and with Sponsor according to SOP.
- Oversee subject interactions in the clinic setting, including
performing phlebotomy to obtain study samples, process and ship
laboratory samples for assigned protocols according to procedures
outlined in the protocol/laboratory manual
- Administering QOL surveys, economic surveys, etc.
- Retrieving oral medication from pharmacy and transporting to
- Coordinating with TPF for biologic collection during surgical
procedures and scheduling patient appointments
- Assessing patients for toxicity under close supervision of
treating physician: consequence of error could be significant
physical harm to research subjects.
- Create Data Management Plan for multiple oncology clinical trials
and direct implementation. Based on knowledge of GCP and research
protocols, identify and modify research methodologies to meet
research objectives as they relate to data collection, reporting,
and analysis, creating and documenting Data Management Plans for
multiple complex trials. Data Management Plan as trial-specific
operating procedures, and to utilize for quality control and
cross-coverage. Lead team in implementing plans, which cover the
o Identification of trends in adverse events and Serious Adverse
Event attribution and reporting to investigators and sponsors.
o Use of concomitant medications by patients, with review
prohibited and cautionary medications as defined per study
o Reporting of data to the sponsor with accuracy, completeness,
legibility, and timeliness.
o Supervision of tracking of subject follow-up for assigned
o Data entry into Oncore and other electronic and paper data
o Review data for accuracy and respond to database queries
- Bachelors degree in related field
- 1 + years of related training or experience required.
- This position requires full knowledge of clinical research
principles as defined by Code of Federal Regulations, Good Clinical
Practice (GCP) Parts 50, 54, 56, 312, 314 and ICH Guidelines;
- Health Insurance Portability and Accountability Act (HIPAA)
- Environment, Health and Safety (EHS) Blood borne Pathogens for
- Transportation of Dangerous Goods, 49CFR 172.700/IATA 1.5/Part 6,
Chapter 1 of ICAO.
- Knowledge of information technology to complete assigned work and
to analyze and report data and information. This knowledge enables
the Study Coordinator to plan and conduct multiple complex trials
and to engage knowledgably with sponsors, investigators, staff, and
subjects to achieve research goals and ensure subject safety.
Keywords: State Of North Carolina, Chapel Hill , Study Coordinator, Other , Chapel Hill, North Carolina
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