[Remote] Senior Clinical Trial Specialist - Remote Position

Note: The job is a remote job and is open to candidates in USA. Puma Biotechnology Inc. is a company focused on developing innovative cancer therapies. The Senior Clinical Trial Specialist is responsible for providing operational support for clinical trials, ensuring compliance with regulatory requirements, and overseeing effective communication among clinical personnel. Responsibilities • Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinical trial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates • Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries) • Coordinates specified clinical trial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes • Sets up, tracks, collects and maintains audit-ready clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings • Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable • Ensures that necessary study supplies are available as per study timelines: sources clinical trial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment • Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance • May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect.In this role, the Sr. CTS may be responsible for: • Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested • Overseeing site recruitment, implementing appropriate contingency plans, as needed • Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations • Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs • Mentors more junior staff • Manages study team meetings in absence of Clinical Trial Manager • Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial Skills • Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field • Strong understanding of GCP, ICH and knowledge of regulatory requirements • Minimum one year prior Clinical Trial Specialist experience or commensurate • Clear and timely communication, both written and verbal • Ability to handle a moderate volume of highly complex tasks within an established timeframe • Strong organizational skills and ability to prioritize • Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff) • Proactively identify and resolve/escalate project-related operational issues • Ability to work independently on routine assignments, and take over new assignments based on previous experience • Familiarity with word processing, spreadsheet and document management systems • One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing) • Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities • Oncology experience • Global trial experience Benefits • Annual bonus target • Robust benefits package Company Overview • At Puma Biotechnology, our focus is on bringing innovative therapies to patients to enhance cancer care. It was founded in 2010, and is headquartered in Los Angeles, California, USA, with a workforce of 201-500 employees. Its website is Apply tot his job