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Gaithersburg

    Quality Assurance Coordinator I - Gaithersburg, United States - CBH Health

    CBH Health
    CBH Health Gaithersburg, United States

    3 weeks ago

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    Description

    About Us:
    Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology.

    Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability.

    We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

    Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.


    Job Summary:
    Ensure that high standards of data quality and subject safety are maintained, as well as study protocols, SOPs/SWPs, ICH/GCP and IRB guidelines, federal regulations are consistently being followed

    Essential Responsibilities and Duties:


    Review assigned study participant study data/source binders/Informed Consents to ensure compliance with study protocols and related guidelinesEnsure all books and subject data are approved prior to monitoring visits and remote source verificationParticipates in study start up activities including the review of source documentation.

    Implement Quality Assurance ProcessesResponsible for Quality Assurance and preparation of study related material for FDA & Sponsor audit with assistance as necessary.

    Ensure proper correction of any queries or issues noted in research dataAttend site initiation meetings and other study related meetings as requiredIdentify needed training programs for clinical research staff based upon quality assurance review and reports.

    Including but not limited to ALCOA, source documentation completion, and overall QA process trainings.
    Evaluate and present Quality Assurance findings/metrics to appropriate staff members and managers.

    Answer inquiries from Operations staff when protocol or study-related questions ariseEscalate and present major findings to the Director of QualityIdentifies and assists in overseeing training programs for study staff and supporting departments based upon review metricsConducts onboarding of new employees and maintains tracking of training statuses for all employeesQuality check of all source documentation after created by staff to ensure ready for current use; creates source on an as needed basisAssumes other duties and responsibilities as assigned.

    The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.


    Education/Experience/Skills:
    Must be able to effectively communicate verbally and in writing.

    Knowledge of ICH-GCP guidelinesAccuracy, thoroughness and attention to detail imperativeSkill in maintaining / reviewing recordsSkill in developing and maintaining effective working relationships with staffAbility to work independently as well as within a teamAbility to effectively present study informationAbility to present a positive image of the clinicAbility to maintain client confidentialitySkill in time management and execute workload with minimal supervisionAbility to foresee potential issues and accurately communicate with the study team to ensure study deadlines are met.

    Working Conditions Indoor, Office environment.
    Essential physical requirements include sitting, typing, standing, walking.
    Lightly active position, occasional lifting of up to 20 pounds.
    Reporting to work, as scheduled, is essential.
    CenExel Clinical Research is an Equal Opportunity Employer.

    All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

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