Seattle, Washington
Clinical Monitor Job Opening in Seattle, Washington - Cancer Research And Biostatistics (CRAB) is a non-profit organization whose purpose is to help conquer cancer and other diseases through the application of biostatistical principles and innovative data management methods.
Position Summary:
With minimal direct supervision, the Clinical Monitor has responsibility to verify that the well-being and rights of human subjects are protected and that clinical trial data reported from source documents are accurate, complete, and verifiable. She/he ensures that the conduct of the trial is in compliance with the currently approved protocol, with GCP as well as with applicable regulatory requirements. Position requires professionalism as she/he interfaces with investigators, site coordinators, statisticians, data management personnel and other industry or federal representatives. This position reports to the Clinical Monitor Manager. Travel is required for this position (up to 70% ).
Duties and Responsibilities:
Travels to, and manages, multiple clinical sites
Performs on-site visits in accordance with the monitoring plan and clinical trial contract or agreement; applies judgment and knowledge to independently resolve site issues, questions and concerns
Verifies that all research staff and facilities have adequate qualifications and resources and that such conditions remain adequate throughout the trial
Verifies that the investigator follows the approved protocol and all GCP requirements such as training. Ensures site adherence to all protocol requirements, including, but not limited to, eligibility confirmation and the prompt submission of data
Verifies that source data, regulatory files, and other trial records are accurate, complete and maintained
Ensures that documentation from investigators and investigational sites meet FDA/ICH-GCP requirements
Reviews study research records including eCRFs, consent forms, AE?s/conmeds and other clinical trial forms to reconcile Case Report Forms against the source documents and site medical records for transcription accuracy. Ensures that all queries are resolved in a timely fashion
Submits routine Monitoring Reports following each site visit within an agreed-upon time frame
Ascertains and recommends appropriate follow-up response to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training
Serves as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols
Acts as direct contact with assigned clinical sites, uses judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
Ensures immediate communication with team regarding any issues that arise at a site
Participates in data management tasking, special projects, and other duties as assigned
Participates as a team member to support data management departmental policies and goals
Required Qualifications:
BA/BS degree in health related field, OR a minimum of four years of experience in a clinical trials research setting as a data specialist/other similar title. Graduation from a education program with a certificate related to clinical trials and/or healthcare regulations will be considered
Ability to travel as required (up to 70%)
Must qualify for rental car contract
Valid driver?s license
Valid U.S. Passport
Desired Knowledge, Skills and Abilities:
Oncology and clinical experience preferred
Comprehensive knowledge of and proficiency using EDCs/EHRs
Significant knowledge of anatomy/physiology, medical terminology and statistics
Knowledge of regulatory documents and guidance?s as well as GCP Guidelines
Experience with on-site monitoring or co-monitoring
Excellent written and verbal communication skills
Expert planning and organization skills
Strong attention to detail
Certification in a recognized research related professional society (SoCRA, SCDM, ACRP)
Ability to use sound judgment and diplomacy while interacting with team members, sponsors, and participating investigative sites
Ability to work well as part of a team or work independently
Proficient in MS Office (Word, Excel, Outlook, PowerPoint)
Ability to be flexible and adapt to new systems
Fluency in Spanish is highly desired
This position is a full-time position and is Exempt from state and federal overtime regulations.
CRAB is an Equal Opportunity Employer.
Employment authorization is required.
Travel/relocation expenses will not be provided for this position.
Job Type: Full-time
Job Location:
Seattle, WA
Required education:
Bachelor's
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