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Study Coordinator

Company: State Of North Carolina
Location: Chapel Hill
Posted on: September 16, 2021

Job Description:

- Implementation of oncology clinical research requires planning and teamwork in order to assure patient safety and research quality.

- Coordinates multiple complex trials through the protocol life cycles of activation, implementation and closure.

- Knowledge of both GCP and full knowledge of individual research protocols

- 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 research goals.

- 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

- 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 Investigator.

- 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 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.

- 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.

- 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:

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 protocol

o Reporting of data to the sponsor with accuracy, completeness, legibility, and timeliness.

o Supervision of tracking of subject follow-up for assigned studies

o Data entry into Oncore and other electronic and paper data capture systems

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 Laboratory

- 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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