Qureos Mentor

AMR Clinical

<div>The role of the Research Assistant is responsible for performing a wide variety of administrative and clinical tasks to support the study site. The Research Assistant supports all study related activities to ensure that the study is completed accurately per study protocol. The Research Assistant is an integral role to assist with the flow of the clinic. 
To consistently embody AMR Clinical&rsquo;s Core Values:<ul><li>
United We Achieve</li><li>
Celebrate Diverse Perspectives</li><li>
Do the Right Thing</li><li>
Adapt and Persevere</li></ul>
The Research Assistant reports to the Site Manager/Team Lead.
Classification: Non-Exempt
Primary Responsibilities:<ul><li>
Effectively prioritize tasks and meet deadlines in a fast-paced environment.</li><li>
Maintain a strong emphasis on compliance responsibilities, including timely identification and reporting of protocol deviations, serious adverse events (SAEs), and adherence to regulatory and site-specific requirements.</li><li>
Monitor &amp; Report Adverse Events &ndash; Recognize and promptly report AEs, protocol deviations, and safety concerns to the clinical team. Document AEs and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.</li><li>
Ensure Compliance with Study Protocols &amp; Regulatory Guidelines &ndash; Adhere to Good Clinical Practice (GCP), FDA regulations, and site SOPs when conducting study-related activities.</li><li>
Assist in Subject Retention Efforts &ndash; Support ongoing engagement, communication, and compliance to enhance subject retention throughout the study.</li><li>
Perform Inventory Management &ndash; Track and manage study supplies, lab kits, and investigational products (if applicable) to ensure readiness for study visits.</li><li>
Assist in maintaining accurate, timely, and audit-ready documentation of all study-related activities.</li><li>
Perform Laboratory Responsibilities with Accuracy &ndash; Ensure proper labeling, handling, storage and shipment of specimens per protocol and regulatory requirements.</li><li>
Strong problem-solving skills and ability to adapt to evolving study requirements.</li><li>
Ability to handle confidential and sensitive information with discretion.</li><li>
Ability to follow detailed instructions and maintain high levels of accuracy.</li><li>
Establish and maintain patient rapport during clinical drug trials to include management of subjects<ul><li>
Clinical data collection such as vital signs, EKG recording, subject weights, etc.</li><li>
Medical record retrieval and review when required</li><li>
Subject interviews</li><li>
Phlebotomy</li><li>
Filing and pulling study records</li><li>
Answering and triage of research office calls</li><li>
Subject check in and out process</li></ul></li><li>
Study preparation, such as screening packets, preparing informed consents, pulling charts for the next business day, etc.</li><li>
Filing study documents in the subject&rsquo;s chart.</li><li>
Develop rapport with study sponsors, monitors, study participants, etc.</li><li>
Assist monitors during onsite visits</li><li>
Maintain accurate enrollment/ICF logs</li><li>
Assist the clinical team to complete study activities. The clinical team includes but is not limited to CRCs, Laboratory, Data management, etc</li><li>
Educate subjects on diaries as studies require.</li><li>
Accurate and timely documentation</li><li>
Unblinded duties as assigned.</li><li>
Position may require occasional weekend and/or overtime hours.</li><li>
Other duties as assigned</li></ul> 
Desired Skills and Qualifications:<ul><li>
Medical office experience, medical certificate, or equivalent work experience preferred.</li><li>
Phlebotomy skills are preferred</li><li>
Excellent attention to detail</li><li>
Strong listening, verbal and written communication skills</li><li>
Excellent task management and organizational skills</li><li>
Ability to multi-task in an always evolving fast paced environment.</li><li>
Demonstrate proficient knowledge of operating office equipment and software.</li><li>
Ability to be ambulatory most of the workday.</li><li>
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.</li><li>
Fluent in English.</li></ul> 
AMR 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.
** 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.</div>

Research Assistant

<div>Data Management Specialist manages data entry from the source documents into CRF&rsquo;s. Specialists collaborate with the clinical study team to take a pro-active approach to identify issues regarding data collection. Data Management Specialist completes data forms and queries in the specified timelines. 
To consistently embody AMR Clinical&rsquo;s Core Values:<ul><li>
United We Achieve</li><li>
Celebrate Diverse Perspectives</li><li>
Do the Right Thing</li><li>
Adapt and Persevere</li></ul>
The Data Management Specialist reports to the Clinical Data Manager.
Classification: Non-Exempt
Primary Responsibilities:<ul><li>
Ensure Compliance with Regulatory &amp; Sponsor Requirements &ndash; Adhere to ICH-GCP, FDA, and sponsor-specific requirements for data management and documentation.</li><li>
Monitor Data Trends &amp; Report Deviations &ndash; Identify patterns in data entry errors and escalate potential protocol deviations or systemic issues to the appropriate team members.</li><li>
Collaborate with Study Teams for Query Resolution &ndash; Work proactively with CRC, QA, and monitors to address open queries and improve data accuracy.</li><li>
Assist in Preparing Sites for Audits &amp; Monitoring Visits &ndash; Ensure data reconciliation, regulatory compliance, and complete documentation before external reviews.</li><li>
Contribute to Study Start-Up &amp; Closeout Activities &ndash; Assist in database lock procedures, final query resolution, and archiving of study records.</li><li>
Ensure timely and accurate CRF completion for each study subject.</li><li>
Review data entered to ensure accuracy</li><li>
Complete CRF data entry in a timely basis according to specified timeline per the protocol.</li><li>
Review source documents for accuracy</li><li>
Maintain source document and logs throughout the study</li><li>
Upload documents into eSource</li><li>
Confirm proper randomization procedures are followed.</li><li>
Schedule and assist with on-site monitor visits.</li><li>
Submit internal queries to clinical staff as needed.</li><li>
Attend site initiation visits for current assigned protocols.</li><li>
Assist with requests from monitors and auditors for completed CRF&rsquo;s and patient records.</li><li>
Develop rapport and maintain professional communication with team members, subjects, sponsors, monitors, etc.</li><li>
Identify trends and systematic issues, escalate to CRC and QA.</li><li>
Complete protocol specific, eSource training as applicable</li><li>
Work with coordinator to complete SAE information if CRF is used in reporting.</li><li>
At study closure, ensure all CRF&rsquo;s are completed, and all data entered as appropriate.</li><li>
Position may require occasional weekend and/or overtime hours.</li><li>
Other duties as assigned</li></ul> 
Desired Skills and Qualifications:<ul><li>
Proficiency in managing confidential and sensitive information with discretion.</li><li>
Strong analytical and problem-solving skills with attention to detail.</li><li>
Experience with data entry programs preferred.</li><li>
Ability to learn and be proficient in various web-based data entry programs.</li><li>
Advance knowledge in operating office equipment and software programs</li><li>
Excellent verbal and written communication skills.</li><li>
Strong interpersonal skills</li><li>
Strong multi-tasking skills and organizational skills</li><li>
Attention to detail</li><li>
Motivated, self starter, and exercises initiative.</li><li>
Excellent follow-up skills.</li><li>
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.</li><li>
Fluent in English.</li></ul> 
AMR 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.
** 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.</div>

Data Management Specialist

<div>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. 
To consistently embody AMR Clinical&rsquo;s Core Values:<ul><li>
United We Achieve</li><li>
Celebrate Diverse Perspectives</li><li>
Do the Right Thing</li><li>
Adapt and Persevere</li></ul>
The Clinical Research Coordinator reports to the Site Manager/Team Lead.
Classification: Non-Exempt
Primary Responsibilities:<ul><li>
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.</li><li>
Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.</li><li>
Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.</li><li>
Establish understanding of SOP&rsquo;s and implement the SOP&rsquo;s</li><li>
Gain understanding of the pharmaceutical drug per clinical trial.</li><li>
Develop detailed knowledge of protocol and procedures per clinical research study.</li><li>
Communicate effectively with study sponsors, CROs, monitors/CRA&rsquo;s, IRBs, laboratories, and clinical personnel within the research industry.</li><li>
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.</li><li>
Establish and maintain patient rapport.</li><li>
Clinical data collection (vital signs, EKG recording, weight, height, etc.)</li><li>
Obtain medical records and review as required.</li><li>
Phlebotomy</li><li>
Specimen collection, processing, and storage</li><li>
Transporting clinical specimens to the laboratory.</li><li>
Educate subjects on diaries and oversees compliance with diary completion.</li><li>
Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.)</li><li>
Responsible for completing patient phone call visits in accordance to the standard protocol period.</li><li>
Ensure documentation follows ALCOA standards and is completed in a timely manner.</li><li>
Ensure all necessary documents are completed, signed and dated.</li></ul><ul><li>
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.</li><li>
Manage study inventory and order supplies as needed.</li><li>
Prepare and assist study monitors during onsite visits.</li></ul><ul><li>
 Maintain familiarity with all ongoing clinical research studies.</li><li>
Travel to Investigator meetings as needed.</li><li>
Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties</li><li>
Position may require occasional weekend and/or overtime hours.</li><li>
Other duties as assigned</li></ul> 
Desired Skills and Qualifications:<ul><li>
1 year of experience in clinical research.</li><li>
Completion of formal medical training, educational program, or healthcare experience</li><li>
Strong medical terminology</li><li>
Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).</li><li>
Ability to work independently and lead study-related tasks.</li><li>
Ability to multi-task in a high-paced evolving environment.</li><li>
Exceptional listening, written, and verbal communication skills as well.</li><li>
Demonstrate proficiency in office equipment and software programs.</li><li>
Excellent organizational and task management skills.</li><li>
Ability to be ambulatory most of the workday.</li><li>
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.</li><li>
Fluent in English.</li></ul> 
AMR 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.
** 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.</div>

Clinical Research Coordinator 1

Join AMR Clinical and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

AMR Clinical

About Company

Research Assistant

Data Management Specialist

Clinical Research Coordinator 1