Experienced Clinical Research Coordinator 2

Alliance For MultiSpecialty Research LLC•Layton, UT

11h

About The Position

The Clinical Research Coordinator II will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator II 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. $1500 sign on bonus for experienced candidates. $750 at 90 days and $750 after 6 months. To consistently embody AMR Clinical’s Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator II reports to the Site Manager/Team Lead. Classification: Non-Exempt

Requirements

2-3 years 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.

Responsibilities

Demonstrate autonomy in protocol execution, regulatory compliance, and study leadership while effectively communicating with study sponsors, CROs, monitors/CRAs, IRBs, laboratories, and clinical personnel within the research industry.
Problem Solving and Critical Thinking. Independently identifies, analyzes, and resolves study-related challenges, including protocol deviations, data discrepancies, and logistical issues. Proactively develops solutions to ensure compliance with study protocols, regulatory requirements, and site-specific procedures while escalating complex issues to the appropriate personnel as needed.
Leadership in training, mentoring, and resolving complex site challenges.
Increased knowledge of protocol and procedures.
Identify and troubleshoot issues related to patient enrollment, protocol deviations, and study compliance, escalating complex cases to investigators or site leadership as needed.
Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.
Handle complex subject situations, including greater involvement surrounding retention challenges, non-compliance, and withdrawal decisions, in collaboration with the PI.
Strong knowledge of FDA regulations, ICH-GCP guidelines, and IRB processes.
Establish understanding of SOP’s and implement the SOP’s
Gain understanding of the pharmaceutical drug per clinical trial.
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 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