Clinical Study Coordinator
Posting ID: JP-002658640
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.
CCRC, Oncology, Clinical Research Coordinator, Clinical Research
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Recruiter: Jean Chambers
Phone: (410) 579-3072