Company: Insight Global
Posted on: January 15, 2022
Clinical Study Coordinator: 6 Month Contract to Hire
Day to Day
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 the 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 research
Serve as the content expert for multiple, complex trials;
instructing other members of the research team as well as staff
from other services which interface in conducting oncology clinical
Establish communication systems and lead conversations to ensure
the 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 the
research team to assess the 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
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 the subject interface
with the 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.
Manage Quality Control process of securing documentation of each
eligibility criterion (typically 30 different criteria for each
research protocol) and overseeing verification by a peer staff
member and Principal Investigator.
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 the Sponsor according to
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 the pharmacy and transporting it to
Coordinating with TPF for biologic collection during surgical
procedures and scheduling patient appointments
Assessing patients for toxicity under close supervision of treating
physician: a 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
Identification of trends in adverse events and Serious Adverse
Event attribution and reporting to investigators and sponsors.
Use of concomitant medications by patients, with review prohibited
and cautionary medications as defined per study protocol
Reporting of data to the sponsor with accuracy, completeness,
legibility, and timeliness.
Supervision of tracking of subject follow-up for assigned
Data entry into Oncore and other electronic and paper data capture
Review data for accuracy and respond to database queries
Bachelor's 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) Bloodborne 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 knowledgeably with sponsors, investigators, staff,
and subjects to achieve research goals and ensure subject
Keywords: Insight Global, Raleigh , Study Coordinator, Other , Raleigh, North Carolina
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