Clinical Research Coordinator 1 - Full-time

/ppemTo consistently embody AMR Clinicalrsquo;s Core Values:/em/pul type="disc"liemUnited We Achieve/em/liliemCelebrate Diverse Perspectives/em/liliemDo the Right Thing/em/liliemAdapt and Persevere/em/li/ulpThe Clinical Research Coordinator reports to the Site Manager/Team Lead./ppClassification: Non-Exempt/ppstrongPrimarynbsp;/strongstrongResponsibilities:/strong/pulliFocuses 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./liliCoordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.nbsp;/liliManage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution./liliEstablish understanding of SOPrsquo;s and implement the SOPrsquo;s/liliGain understanding of the pharmaceutical drug per clinical trial. nbsp;/liliDevelop detailed knowledge of protocol and procedures per clinical research study./liliCommunicate effectively with study sponsors, CROs, monitors/CRArsquo;s, IRBs, laboratories, and clinical personnel within the research industry.nbsp;/liliBe 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./liliEstablish and maintain patient rapport.nbsp;/liliClinical data collection (vital signs, EKG recording, weight, height, etc.)/liliObtain medical records and review as required.nbsp;/liliPhlebotomy/liliSpecimen collection, processing, and storage/liliTransporting clinical specimens to the laboratory.nbsp;/liliEducate subjects on diaries and oversees compliance with diary completion.nbsp;/liliProvides subjects instructions per study (diaries, restricted meds, study reminders, etc.)/liliResponsible for completing patient phone call visits in accordance to the standard protocol period.nbsp;/liliEnsure documentation follows ALCOA standards and is completed in a timely manner.nbsp;/liliEnsure all necessary documents are completed, signed and dated.nbsp;/li/ulul type="disc"liProvides 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./liliManage study inventory and order supplies as needed.nbsp;/liliPrepare and assist study monitors during onsite visits./li/ulullinbsp;Maintain familiarity with all ongoing clinical research studies.nbsp;/liliTravel to Investigator meetings as needed.nbsp;/liliPromote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties/liliPosition may require occasional weekend and/or overtime hours.nbsp;/liliOther duties as assigned/li/ulpstrongunbsp;/u/strong/ppstrongDesired Skills and Qualifications:/strong/pulli1 year of experience in clinical research./liliCompletion of formal medical training, educational program, or healthcare experience/liliStrong medical terminology/liliAbility to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).nbsp;/liliAbility to work independently and lead study-related tasks.nbsp;/liliAbility to multi-task in a high-paced evolving environment.nbsp;/liliExceptional listening, written, and verbal communication skills as well.nbsp;/liliDemonstrate proficiency in office equipment and software programs.nbsp;/liliExcellent organizational and task management skills. nbsp;/liliAbility to be ambulatory most of the workday./liliAbility to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination./liliFluent in English./li/ulpnbsp;/ppemAMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor./em/ppem** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description./em/ppbr/p/div
divp id="isPasted"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.nbsp;/ppnbsp;/ppemTo consistently embody AMR Clinicalrsquo;s Core Values:/em/pul type="disc"liemUnited We Achieve/em/liliemCelebrate Diverse Perspectives/em/liliemDo the Right Thing/em/liliemAdapt and Persevere/em/li/ulpThe Clinical Research Coordinator reports to the Site Manager/Team Lead./ppClassification: Non-Exempt/ppstrongPrimarynbsp;/strongstrongResponsibilities:/strong/pulliFocuses 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./liliCoordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.nbsp;/liliManage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution./liliEstablish understanding of SOPrsquo;s and implement the SOPrsquo;s/liliGain understanding of the pharmaceutical drug per clinical trial. nbsp;/liliDevelop detailed knowledge of protocol and procedures per clinical research study./liliCommunicate effectively with study sponsors, CROs, monitors/CRArsquo;s, IRBs, laboratories, and clinical personnel within the research industry.nbsp;/liliBe 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./liliEstablish and maintain patient rapport.nbsp;/liliClinical data collection (vital signs, EKG recording, weight, height, etc.)/liliObtain medical records and review as required.nbsp;/liliPhlebotomy/liliSpecimen collection, processing, and storage/liliTransporting clinical specimens to the laboratory.nbsp;/liliEducate subjects on diaries and oversees compliance with diary completion.nbsp;/liliProvides subjects instructions per study (diaries, restricted meds, study reminders, etc.)/liliResponsible for completing patient phone call visits in accordance to the standard protocol period.nbsp;/liliEnsure documentation follows ALCOA standards and is completed in a timely manner.nbsp;/liliEnsure all necessary documents are completed, signed and dated.nbsp;/li/ulul type="disc"liProvides 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./liliManage study inventory and order supplies as needed.nbsp;/liliPrepare and assist study monitors during onsite visits./li/ulullinbsp;Maintain familiarity with all ongoing clinical research studies.nbsp;/liliTravel to Investigator meetings as needed.nbsp;/liliPromote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties/liliPosition may require occasional weekend and/or overtime hours.nbsp;/liliOther duties as assigned/li/ulpstrongunbsp;/u/strong/ppstrongDesired Skills and Qualifications:/strong/pulli1 year of experience in clinical research./liliCompletion of formal medical training, educational program, or healthcare experience/liliStrong medical terminology/liliAbility to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).nbsp;/liliAbility to work independently and lead study-related tasks.nbsp;/liliAbility to multi-task in a high-paced evolving environment.nbsp;/liliExceptional listening, written, and verbal communication skills as well.nbsp;/liliDemonstrate proficiency in office equipment and software programs.nbsp;/liliExcellent organizational and task management skills. nbsp;/liliAbility to be ambulatory most of the workday./liliAbility to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination./liliFluent in English./li/ulpnbsp;/ppemAMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor./em/ppem** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description./em/ppbr/p/div