Clinical Research Coordinator

Integrated Resources, Inc

Chapel Hill, NC

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JOB DETAILS

JOB TYPE

Contractor

SKILLS

Case Report Form (CRF), Clinical Research, Clinical Trial, Conduct Studies, Data Collection, Data Quality, Documentation, Electronic Medical Records, Epic Systems, GCP (Good Clinical Practices), Informed Consent, Laboratory Operations, Medical Records, Occupational Health, Organizational Skills, Problem Solving Skills, Process Improvement, Project/Program Management, Quality Assurance, Quality Control, Regulations, Regulatory Submissions, Research Laboratory, Research Protocols, Site Initiation, Standard Operating Procedures (SOP), Startup, Testing, Vaccination

LOCATION

Chapel Hill, NC

POSTED

30+ days ago

Job Title: Clinical Research Coordinator 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. Duties and 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. Minimum Requirements: One year of experience of patient facing clinical research experience. Preferred Qualifications: 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. Must Have: 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. Nice to Have: 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.

About the Company

Integrated Resources, Inc

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