Senior Clinical Research Associate, Dermatology & Rheumatology CRO, Arizona, Nevada, Oregon

Senior Clinical Research Associate, Dermatology & Rheumatology (Oregon, Nevada, Arizona,)The senior clinical research associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.This role will be perfect for you if:You are an experienced CRA with a demonstrated ability to work autonomously to meet quality standards and deadlinesFocusing on dermatology and developing an expertise in this therapeutic area is interesting to youYou enjoy working for a mid-sized CRO where your contributions are noticed and valuedRESPONSIBILITIES The senior clinical research associate (CRA):Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulationsParticipates in investigators’ meetingsPrepares site visit reports and follow-up letters to the investigatorBuilds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targetsPerforms source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequateThe Sr CRA may also assume the following Lead CRA responsibilities: Reviews and approves site visit reports. Tracks site visit and trip report metrics and escalates issues to project teams. Recommends potential solutions to identified issues and work with the project managers to find resolution. Supports the development of annotated site visit reports, clinical monitoring plans, and monitoring tools. Supports the preparation and development of materials related to the training of CRAs. Mentors CRAs. Conducts on-site quality control visits with CRAs.

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