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Puma Biotechnology, Inc. · 23 hours ago

Senior Clinical Trial Specialist - Remote Position

United States

Full-time

Remote

Mid, Senior Level

$90K/yr - $100K/yr

1+ years exp

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.

BiotechnologyMedicalTherapeutics

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

Qualification

GCP knowledgeClinical Trial experienceRegulatory requirementsOncology experienceGlobal trial experienceWord processingSpreadsheet proficiencyClear communicationOrganizational skillsRelationship buildingProblem-solving