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Deerfield Beach

    Senior Clinical Research Coordinator - Deerfield, United States - ICONMA

    ICONMA
    ICONMA Deerfield, United States

    3 weeks ago

    ICONMA background
    Description

    Senior Clinical Research Coordinator Location:

    Deerfield, IL/ Chicago, IL/HybridDuration: 12 months with possible contract to hire/ with possible extensionDescription: The Senior Clinical Research Coordinator (CRC) is responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned trials.

    Working in collaboration with the Principal Investigator, the Sr.

    CRC is responsible for the oversight, facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study.

    The Sr.

    CRC works collaboratively with the entire team, sponsors, and Clinical Quality Associates to ensure productivity, quality, and timely completion of studies.

    The Sr.

    CRC is expected to support, guide, train, demonstrate and lead clinical trial team members in the implementation of trial related activities.

    The Sr.

    CRC applies critical thinking and creative problem-solving skills across a wide variety of clinical studies, and contributes to the development of new processes, procedures, tools and training to enhance clinical research activities and is accountable for adhering to quality standards.


    Job Responsibilities:

    Manages and oversees the day-to-day operations in the administration of clinical trial activities at the site-level (i.e., direct interactions with study participants)Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocolCreates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulationsContributes to the training of clinical trial staff and accountable for compliance with the operational requirements of the clinical trialFunction as participants' primary point of contact, keeping them informed on the study progress, and facilitate involvement of other study team members, as needed (e.g., notify Principal Investigator of safety events)Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s)Solicit and record information regarding safety events and preparing safety event documentation for review by the Principal InvestigatorProvides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Client databasesSupports the regulatory staff in the maintenance of regulatory documents in accordance with Client SOPs and applicable regulationsCommunicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participantsMaintain regular contact with the Principal Investigator and team to review study details (e.g., progress, adverse events, enrollment)Maintain study supplies and issue appropriate participant stipendsEnsures appropriate credentialing and training of the study teamFacilitate meetings with the study monitors, auditors, and investigatorsEnsure timely response to queries and documentation of study-related issuesIf applicable, disburses investigational product, manages inventory of equipment and study supplies, and provides patient education regarding administration, as necessaryContribute to the development and implementation of tools, processes and training to enhance the administration and execution of clinical studies (e.g., GCP, ALCOA-C)Accountable for site compliance with subject safety reporting, escalate issuesDemonstrate professionalism and apply basic leadership practices in all aspects of the roleTrain and support study team members on a range of communication and teamwork best practicesPerforms other duties related to the clinical trials as delegated by the Principal InvestigatorOpportunity to be a part of clinical trials in a pharmacy.

    Bringing the trials to the people at their local pharmacy. Working on all trials within the delivery operation team.


    Experience:

    3-5 years in clinical trial space Education: BA Skills: Working knowledge of ICH-GCP, US CFR, and HIPAA regulations Experience working independently and making appropriate decisions to operationalize and move clinical trials forward Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities Preferred: Proficient with phlebotomy Decentralized/hybrid clinical trials experience As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability.

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