Job Description

Immediate Opening! Great Pay! Excellent Benefits! Room for Growth! This Jobot Job is hosted by: Juan Correa Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $110,000 - $120,000 per year A bit about us: We are a clinical stage biotech company focused on innovative discovery research and clinical development in oncology. The company received three IND clearances from the FDA recently: PT199 for solid tumors, PT886 for pancreatic, GEJ and gastric cancers, and PT217 for small cell lung cancer (SCLC). Why join us? Competitive Base Salary! Extremely Competitive Equity Package! Flexible Work Schedules! Accelerated Career Growth! Job Details Job Summary: This position is in the clinical operations function located at our office in San Diego, CA. Under the supervision of the Clinical Operations Director, the Clinical Research Associate (CRA) is responsible for conducting all aspects of site monitoring for clinical research studies according to our Standard Operating Procedures (SOPs) and ICH/GCP/GLP guidelines. Key Responsibilities: Conducts pre-study (site qualification), initiation, routine monitoring and closeout visits and ensures these visits are completed according to the Clinical Monitoring Plan(s) and SOPs. Trains the study investigators and staff during the SIV and to trial-specific updates, all to industry standards Prepares site visit reports and sends confirmation/follow-up letters to sites per the Clinical Monitoring Plan(s) Conducts and documents periodic telephone contact with sites in accordance with the Monitoring Plan Verifies data entered into the case report forms (CRFs) is consistent with subject clinical records, electronic medical records and source data to ensure accuracy Ensures data collection timelines and deliverables are met at assigned clinical sites in accordance with study plans Works with Data Management to ensure the query resolution process is followed and completed Identifies and reports protocol deviations in accordance with the Protocol Deviation Plans and monitors site submission to the IRB/EC per reporting policies Ensures site compliance to SAE reporting policy per protocol and with the Safety Management Plans Ensures site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites. Immediately reports non-compliance to the CTM and/or head of clinical operations Assists the CTM and/or head of clinical operations in the development and implementation of corrected actions for the addressing non-compliance issues at individual sites and across study, including timely follow-up to routine and for-cause Quality Assurance audits Work with investigators on their subject recruitment and screening strategies Tracks and reports progress of assigned sites, including study start up, subject screening/enrollment, data collection, adverse event documentation and Frequently Asked Questions document updates Partners with the in-house CTAs and/or CRAs in the collection, review, and tracking of essential documents to ensure completeness of both site files and eTMF Upload documents into the eTMF and completes coding and QCs as required Assists with planning, preparing, distributing and presenting materials for Investigator Meetings and for study-related trainings Provides ongoing study-related training (i.e., EDC) and support to site staff as necessary Works with Clinical Team in the management of Investigational Product (IP) at clinical sites Manages inventory of clinical supplies at assigned sites and monitors the documentation of returns/destruction as appropriate May collaborate with the head of clinical operations and/or in-house CTM/CTA/CRAs on the development of certain study-specific plans and/or processes Ensure proper collection, storage and shipment of laboratory specimens Participates in Clinical Trial Team Meetings Other duties as assigned by the Head of Clinical Operations. Qualifications: Bachelor’s Degree (BA/BS) in life sciences or nursing degree Minimum of five (5) or more years of relevant experience in clinical research or healthcare related industry, including a minimum of 2 years direct field monitoring experience, or equivalent combination of education and experience Independent site monitoring experience in all phases of clinical trials (phase 1, 2, and 3) Experience in oncology is highly preferred Experience/training in the following areas: GCP Regulations, ICH Guidelines, Good Quality Practices, 21CFR, HIPAA, Drug Development and Approval Process Proficiency with MS Office Excellent oral and written communication skills including presentation skills Ability and willingness to travel to investigational sites for on-site monitoring visits, up to 70% of the time. Ability to perform virtual monitoring remotely as needed Interested in hearing more? Easy Apply now by clicking the "Apply" button.

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