Clinical Scientist/Operations Specialist

Clinical Scientist/Operations Specialist The Clinical Scientist/Operations Specialist is responsible for providing operational expertise to support the day-to-day execution of clinical trials, to follow established SOPs, GCP and applicable regulatory requirements in the execution of all activities and to proactively identify and resolve operational project issues. Responsibilities: Participates in selection, management and oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and Participates in study design and execution by contributing operational experience: 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. Coordinates specified clinical trial meetings (eg, investigator meetings, DSMB meetings, study team meetings, CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes. Maintains ongoing communication with vendors and site staff to resolve issues (eg, data queries and data entry, study management, protocol deviations), support the site staff, oversee the efficient conduct of the trial, and ensure continued compliance. Ensures necessary study supplies are available per study timelines: sources clinical trial supplies through external vendors (eg, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment. Assures trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in Conducts 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 as requested and writes confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs. Stays up-to-date with industry developments and trends to identify opportunities for process Serves as the clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., Institutional Review Board (IRB), sites) Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the Requirements: Degree in life sciences, nursing, or related field; Advanced degree (Pharm , Ph.D., Master's) preferred At least 5 years of experience in clinical operations, oncology experience preferred Strong knowledge of FDA regulations and guidelines Excellent communication skills, both written and verbal Ability to work independently and as part of a team Strong problem-solving and critical thinking skills Willingness to travel as needed for site visits and meetings To apply, please submit your CV to