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 careers@anixa.com.

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