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AMR Clinical · 1 day ago

Clinical Research Coordinator

Kansas City, MO

Full-time

Onsite

Entry Level

$24/hr - $27/hr

1+ years exp

AMR Clinical is focused on conducting clinical research studies and is seeking a Clinical Research Coordinator to manage essential tasks for these studies. The role involves ensuring compliance with regulations, managing clinical trials, and maintaining effective communication with various stakeholders throughout the research process.

BiotechnologyHealth CarePharmaceutical

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

Qualification

Clinical research experienceCompliance with FDA regulationsGCP Guidelines knowledgeMedical terminologyPhlebotomyTask managementMulti-taskOffice softwareCommunication skillsOrganizational skillsTeamwork