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Clinical Research Coordinator
2 weeks ago
Job Location: Chapel Hill, NC
Job Summary:
- 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.
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.).
- 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.
- One year of experience of patient facing clinical research experience.
- Experience in clinical research.
- EPIC medical records experience.
- SOM employees that work in a clinical environment must provide verification of vaccination using the COVID-19 Vaccine Certification Form or have received a medical or religious exemption through client Employee Occupational Health by Sept. 21 to maintain their clinical privileges.
- Preference will be given to an individual with excellent problem-solving skills, organizational skills, ability to exercise excellent judgment, work independently and make sound decisions in the absence of formal guidelines.
- This person should be resourceful.
- Prefer individual with working knowledge of EPIC.
- Working knowledge of and the ability to interpret and apply a wide variety of departmental, University, State, and Federal policies and procedures is preferred.
