Clinical Research Coordinator 1

The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt

Primary Responsibilities

• 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

Desired Skills and Qualifications

• 1 year of experience in clinical research.
• Completion of formal medical training, educational program, or healthcare experience
• Strong medical terminology
• Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).
• Ability to work independently and lead study-related tasks.
• Ability to multi-task in a high-paced evolving environment.
• Exceptional listening, written, and verbal communication skills as well.
• Demonstrate proficiency in office equipment and software programs.
• Excellent organizational and task management skills.
• Ability to be ambulatory most of the workday.
• Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.
• Fluent in English.