Clinical Research Coordinator 1

Responsibilities

• •The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies
• •The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study
• •Adapt and Persevere
• •The Clinical Research Coordinator reports to the Site Manager/Team Lead
• •Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent
• •Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures
• •Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols
• •Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution
• •Establish understanding of SOP’s and implement the SOP’s
• •Gain understanding of the pharmaceutical drug per clinical trial
• •Develop detailed knowledge of protocol and procedures per clinical research study
• •Communicate effectively with study sponsors, CROs, monitors/CRA’s, IRBs, laboratories, and clinical personnel within the research industry
• •Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study
• •Establish and maintain patient rapport
• •Clinical data collection (vital signs, EKG recording, weight, height, etc.)
• •Obtain medical records and review as required
• •Phlebotomy
• •Specimen collection, processing, and storage
• •Transporting clinical specimens to the laboratory
• •Educate subjects on diaries and oversees compliance with diary completion
• •Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.)
• •Responsible for completing patient phone call visits in accordance to the standard protocol period
• •Ensure documentation follows ALCOA standards and is completed in a timely manner
• •Ensure all necessary documents are completed, signed and dated
• •Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required
• •Manage study inventory and order supplies as needed
• •Prepare and assist study monitors during onsite visits
• •Maintain familiarity with all ongoing clinical research studies
• •Travel to Investigator meetings as needed
• •Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties
• •Position may require occasional weekend and/or overtime hours
• •Other duties as assigned
• •29 more items(s)