Clinical Research Coordinator
Location: Chapel Hill
Posted on: January 11, 2022
Clinical Research Design and Administration
Implementation of oncology clinical research requires planning and
teamwork in order to assure patient safety and research quality.
The Study Coordinator coordinates multiple complex trials through
the protocol life cycles of activation, implementation and closure.
These trials are complex, requiring full knowledge of both GCP and
full knowledge of individual research protocols; consequence of
error could be significant physical harm to research subjects.
Study Coordinators independently plan, organize, and evaluate
implementation of multiple oncology clinical research projects with
knowledge of, and in compliance with, sponsor requirements. For
each trial, acquire full knowledge of research protocol and related
documents, plan and document methodologies for research subject and
data management based on this knowledge.
Study Coordinators train others in research methodology and direct
the work of team members and staff from other services to complete
Training, Communication & Instruction
*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
Research Subject Management
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. Eligibility criteria serve the purpose
of protect patient safety by excluding patients who may be at
increased risk because of existing conditions, previous exposures,
and parameters of their existing health: consequence of error could
be significant physical harm to research subjects. Study
Coordinators are expected to conduct this aspect of clinical
research in close communication with the Principal Investigator.
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 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 Sponsor according to SOP.
*Following research protocol and Subject Management Plan, lead
activities of research team to manage subject interactions through
treatment and follow up.
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 subject; 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. This position may
perform these tasks or direct some to lower level staff to
Research Data Management
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
This position may perform these tasks or direct lower level staff
to accomplish them.
Knowledge, skills, and abilities required:
Knowledge - Professional: 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 Laboratory; Transportation of Dangerous
Goods, 49CFR 172.700/IATA 1.5/Part 6, Chapter 1 of ICAO. This
position also requires 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.
Project Design: This position requires the ability to identify,
evaluate and modify clinical research methodology and the ability
to provide consultation on conduct of research. These abilities are
necessary to create, modify, and oversee coordination research and
the research plans for subject and data management.
Social/Clinical Research Project/Program Administration: This
position requires the ability to plan work to meet established
deadlines; the ability to assess the needs of multiple projects and
make changes in process and assignments; the ability to lead
multiple, concurrent assignments, and the ability to create as
multiple, concurrent assignments, and the ability to create as well
as follow established guidelines for assessing compliance with
protocol and manuals of operational procedures. These skills are
necessary to independently plan, organize, and evaluate
implementation of multiple oncology clinical research projects.
Data/Information Analysis/Management: This position requires the
ability to analyze data/information for accuracy, validity and
integrity and to maintain quality control and assurance; the
ability to apply criteria for extract of data; the ability to
prepare reports and/or presentations; and the ability to develop
guidelines for implementation procedures. This competency is
required in maintaining quality of research conducted by the
Clinical Protocol Office.
Communication: This position requires the ability to lead the
exchange of research information through technical assistance and
instruction, to contribution to the preparation of publications and
policies; and the ability to independently provide consultation
related to multiple specific projects. These skills are required to
coordinate research and to provide training and instruction to
staff and others.
CCRC, Oncology, Clinical Research Coordinator, Clinical
Top Skills Details:
CCRC,Oncology,Clinical Research Coordinator
Additional Skills & Qualifications:
Instruction: This position requires the ability to train others in
the performance of methodologies necessary to conduct clinical
research and to document research methodologies. These skills are
required to develop Subject and Data Management Plans, t
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Keywords: Actalent, Chapel Hill , Clinical Research Coordinator, Healthcare , Chapel Hill, North Carolina
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