Clinical Research Coordinator- Chapel Hill, NC
Company: Aerotek
Location: Chapel Hill
Posted on: January 10, 2021
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Job Description:
Description: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 research goals. 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
services. 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 including: 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 procedures. 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 accomplish them. 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
following areas: *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 studies *Data entry into Oncore
and other electronic and paper data capture systems *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 well
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.Skills:CCRC,
Oncology, Clinical Research Coordinator, Clinical ResearchTop
Skills Details:CRC, Oncology, Clinical Research
CoordinatorAdditional 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, tExperience Level:Entry
LevelAbout Aerotek:We know that a company's success starts with its
employees. We also know that an individual's success starts with
the right career opportunity. As a Best of Staffing-- Client and
Talent leader, Aerotek's people-focused approach yields competitive
advantage for our clients and rewarding careers for our contract
employees. Since 1983, Aerotek has grown to become a leader in
recruiting and staffing services. With more than 250 non-franchised
offices, Aerotek's 8,000 internal employees serve more than 300,000
contract employees and 18,000 clients every year. Aerotek is an
Allegis Group company, the global leader in talent solutions. Learn
more at Aerotek.com.The company is an equal opportunity employer
and will consider all applications without regards to race, sex,
age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any
characteristic protected by law.
Keywords: Aerotek, Chapel Hill , Clinical Research Coordinator- Chapel Hill, NC, Healthcare , Chapel Hill, North Carolina
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