At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.
 

POSITION SUMMARY:

The incumbent is accountable for the day-to-day clinical site monitoring of Lyell’s clinical trials and is based in Seattle, Washington. The Clinical Research Associate (CRA) is responsible for coordinating and overseeing the clinical sites in the execution of the clinical trials. They CRA will coordinate efforts on recruiting study participants to creating and reviewing study documentation, collecting patient data, and performing monitoring visits to ensure study protocols are being followed.

KEY ROLE AND RESPONSIBILITIES:

  • Participates in the development of clinical trial protocols and clinical study plans, study specific templates, forms, logs and trackers.
  • Participates in the identification of CROs and centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities and participates in final selection.
  • Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
  • Participates in site feasibility and selection, conduct pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites, support and coordinate with the Clinical Research Associates (CRAs) from the Contract Research Organizations CROs on these activities, ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Conducts clinical trial site initiation visits; advises and trains site personnel on regulatory requirements for study conduct; participates and/or conducts remote or on-site meetings and multicenter investigator meetings and prepares reports, or support  and coordinate with the CROs CRAs on these activities, ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions.
  • Conducts site monitoring visits and follow-up on screening and enrollment activities and targets, identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies, or support and coordinate with the CROs CRAs on these activities, ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Reviews Site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required. Reconciles contents of the Investigator Site File (ISF) with the Trial Master File (TMF). Confirm that the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations, or support and coordinate with the CROs CRAs on these activities.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues, or support and coordinate with the CROs CRAs on these activities.
  • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
  • Confirms appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems and clarifies and/or obtains changes to data as appropriate, or support and coordinate with the CROs CRAs on these activities.
  • Assists in the close-out of clinical sites; assembles necessary documents, conducts site close-out visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study close-out reports.
  • Supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of the study.
  • Coordinate with Institutional Review Boards (IRBs) or ethics committees to safeguard the rights, safety and wellbeing of all research subjects and research activities or support and coordinate with the CROs CRAs on these activities.
  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance, or support and coordinate with the CROs CRAs on these activities.
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • Daily interaction with Clinical Operations management and members of the cross-functional study team.
  • Work with the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., CRO, Vendors, Regulatory, Investigators Sites, vendors, etc.).
  • Lead and partake in regular team meeting / teleconferences; Participate/present at CRO, Vendor and Investigator Site meetings as necessary; Participate/present at Site and Investigator Meetings as necessary.
  • Communicate any Site, CRO or Vendor escalations or issues to upper management as soon as identified.

 PREFERRED EDUCATION:

  • Bachelor’s Degree in biomedical sciences or related scientific discipline; or sufficient work experience in related field with 5+ years of clinical sample monitoring experience required

 PREFERRED EXPERIENCE:

  • Demonstrates experience working with cross-functional teams
  • Extensive experience working with clinical protocols
  • An experienced, strong collaborator, effective at influencing internally and externally, and proactive in a fast-paced environment
  • Work experience in a highly regulated environment (ICH/GCP)

KNOWLEDGE, SKILLS AND ABILITIES:

  • Oncology Experience
  • Cell therapy Experience
  • Excellent verbal and written communication skills required.
  • Excellent organizational, multi-tasking and time management skills required.
  • Sound knowledge of medical terminology and clinical trial management process.
  • Knowledge of FDA regulations and International Council for Harmonization Good Clinical Practice guidelines
 
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
 
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.  The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
 
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.

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