UTS - Temporary Clinical Research Coordinator at UNC Chapel Hill

UNC-Chapel Hill•Chapel Hill, NC

1d•Onsite

About The Position

The Research Assistant is responsible for supporting the lead coordinators in coordinating multiple complex trials through the protocol life cycles of activation, implementation and closure.

Requirements

Supporting the lead coordinators in coordinating multiple complex trials through the protocol life cycles of activation, implementation and closure.
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.)
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.
Screen and recruit study participants for studies per study protocol and applicable standard operating procedures.
Obtain informed consent from study participants.
Participate in basic study start-up activities.
Participate in site initiation visits, study start-up meetings, and closeout visits for research studies.
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.
Maintain study supplies (e.g., laboratory kits, administrative supplies).
Track and ship biospecimens, as applicable.

Responsibilities

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.)
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.
Screen and recruit study participants for studies per study protocol and applicable standard operating procedures.
Obtain informed consent from study participants.
Participate in basic study start-up activities.
Participate in site initiation visits, study start-up meetings, and closeout visits for research studies.
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.
Maintain study supplies (e.g., laboratory kits, administrative supplies).
Track and ship biospecimens, as applicable.