[Remote] Senior Clinical Research Associate - Remote Position

Note: The job is a remote job and is open to candidates in USA. Puma Biotechnology Inc. is a company focused on innovative cancer therapies, and they are seeking a Senior Clinical Research Associate to act as a central communication point between the company and investigative sites. The role involves ensuring that clinical trials are conducted efficiently and in compliance with regulatory standards, while also maintaining relationships with site staff and overseeing trial activities.ResponsibilitiesMaintains on-going communication with sites to respond to questions, resolve issues (eg, data queries, study management), support the site staff, oversee the efficient conduct of the trial, and ensure continued complianceFacilitates preparation and collection of site level documentsAssesses site performance and conducts training/re-training when necessary to ensure site compliance with the protocol, applicable regulations, and Puma expectationsDevelops and maintains relationships with clinical site investigators and other site staffAssists site staff in maintaining audit/inspection readiness and in responding to any observations made by the auditor/inspectorEscalates site issues and collaborates with the study team and site staff to resolve issuesParticipates in and contributes to study-specific team meetingsPerforms other tasks, as assigned by the manager/Clinical Operation Lead/designee, to promote the efficient conduct of the studyConducts all activities involved in on-site visits consistent with the applicable Clinical Monitoring Plan (CMP), SOPs, and ICH GCP for site qualification, site initiation, interim monitoring, site close-out, and other site visits (eg, booster visits)Writes confirmation letters, follow-up letters, and site visit reports that conform to guidelines and timelines as stated in the applicable CMP and SOPsReviews and approves site-specific informed consent formsSubmits documents to a central Institutional Review Board on behalf of investigative sitesReviews site visit reports as well as confirmation and follow-up letters written by field CRAs, and provides timely feedbackMentors less-experienced CRAsManages study team meeting in the absence of the Clinical Trial ManagerPerforms additional activities as assigned:Assists with budget negotiations under the direction of the Director/designeeManages Clinical Operations vendors under the direction of the Director/designeeRepresents Puma at key therapeutic meetingsMaintains operational expertise to support Clinical Science Liaison personnelConducts strategic negotiations with site staffSkillsBachelor's degree or equivalent combination of education/experience, preferably in science or a health-related fieldMinimum of five years of health-related experience (eg, study coordinator, research lab, pharmaceutical/biotech company, CRO) or equivalent, including minimum of three years of CRA experienceStrong understanding of ICH GCP and knowledge of FDA regulatory requirements related to clinical researchClear and timely communication, both written and verbalAbility to handle a moderate to high volume of highly complex tasks within an established timeframeStrong organizational skills and ability to prioritizeAbility to build relationships within the team, across departments, and with external contacts (eg, site staff, vendors)Proactively identify and resolve/escalate project-related operational issuesAbility to work independently on routine assignments, or under supervision on new assignmentsFamiliarity with word processing and spreadsheet programs, document management systems, and electronic data capture applicationsOncology experienceGlobal trial experiencePrevious field monitoring experienceBenefitsAn annual bonus targetA robust benefits packageCompany OverviewAt 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 http://www.pumabiotechnology.com.