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NC State University is seeking a Temporary Clinical Research Coordinator to manage complex clinical trials at UNC Chapel Hill. Responsibilities include coordinating research projects, maintaining study documentation, and ensuring compliance with regulations. Candidates should possess a Bachelor's degree and relevant clinical experience.
The Study Coordinator is responsible for coordinating 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.
The individual will need to independently plan, organize, and evaluate implementation of multiple clinical research projects with knowledge of, and in compliance with, sponsor requirements. For each trial, they will need to acquire full knowledge of research protocol and related documents, plan and document methodologies for research subject and data management based on this knowledge.
Is Time Limited
Is Time Limited Yes
If Yes, Appointment Length TBD
Department Information
Job City & State
Department
System Information
Classification Title
Classification Title Temporary-Service Maintenance
Working Title
Working Title UTS-Temporary Clinical Research Coordinator at UNC Chapel Hill
Requirements and Preferences
Work Schedule
Work Schedule Monday–Friday, 8:00 AM–5:00 PM
Other Work/Responsibilities
Research Study Execution
* Collect study data through a variety of methods, per study protocol (e.g., administer surveys, observe/conduct study activities and record outcomes, electronic medical record data abstraction, biospecimens).
* Perform clinical tests and procedures in accordance with the study protocol, following adequate training.
* Record and organize study data and complete applicable case report forms (electronic or paper) as required in accordance with good clinical practice and ALCOA -C principles.
* Manage study visits as applicable (e.g., schedule/coordinate visits, prepare materials, manage research charges, etc.)
Research- Subjects/Ethics
* Maintain administrative study documentation (e.g., delegation of authority logs, training records)
* Assist in the development and submission of regulatory applications and/or study materials (e.g., recruitment materials, informed consent forms)
* Gather and store required regulatory documentation.
* Prepare for study monitoring, participate in monitoring visits, and assist with corrections as applicable.
* Track and document protocol deviations and adverse events.
Participant Management
* Screen and recruit study participants for studies per study protocol and applicable standard operating procedures.
* Obtain informed consent from study participants.
Research- Project Management
* Participate in basic study start-up activities.
* Participate in site initiation visits, study start-up meetings, and closeout visits for research studies.
Research- Quality Control
* Ensure accuracy of data collected by conducting quality assurance/quality control procedures.
* Report variations or discrepancies in data collected. Recognize discrepancies in patterns and make recommendations for process improvement.
Research- Lab Operations
* Maintain study supplies (e.g., laboratory kits, administrative supplies).
* Track and ship biospecimens, as applicable.
Preferred Years Experience, Skills, Training, Education
Required fields are indicated with an asterisk (*).
(Open Ended Question)
(Open Ended Question)
Required Documents
NC STATE UNIVERSITY
RALEIGH, NC 27695
PHONE: (919) 515-2011