Senior Clinical Trials Operations Specialist

5 days ago

San Francisco, California, United States Lifelancer Full time
Job Description

The Senior Clinical Trials Operations Specialist is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required.

Major duties include:

  • Ensuring timely and accurate study-related communication to clinical personnel (e.g., internal and external study teams, consultants, and investigative site personnel); preparing and disseminating clinical trial correspondence, newsletters, and IND safety letters (working with project clinicians); and assisting with the creation of study-specific manuals, tools, and templates
  • Participating in selection and management/oversight of external vendors and developing vendor specifications; reviewing vendor reports, budgets, and metrics; acting as liaison between vendors and sites (e.g., assisting sites with laboratory sample queries)
  • Coordinating specified clinical trial meetings (e.g., 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 (e.g., 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 (e.g., data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance

In addition, the Senior Clinical Trials Operations Specialist 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 (e.g., 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

Skills and Abilities:

  • 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 (e.g., 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

Lifelancer offers competitive compensation for this role, with a salary range of $85,000 - $105,000 per year. Benefits include opportunities for professional growth and development, a collaborative and dynamic work environment, and a comprehensive benefits package.

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