Clinical Trial Assistant

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 science. We are a learning organization dependent on deep collaborative relationships between our colleagues, partners, and founders. Our culture is based on Science, Respect, Collaboration and Courage, and reflects who we are and the environment we create.

 

POSITION SUMMARY:

You will be responsible for the day-to-day support of Lyell’s clinical studies. Assisting and providing support to the members of the clinical operations project team in order to facilitate the management clinical trial processes including planning, execution, and closeout of outsourced clinical trials. You will ensure that the trial is conducted in compliance with the protocol, ICH good clinical practice, applicable regulatory requirements and applicable standard operating procedure work instructions. This role may be responsible for managing specific study and operational tasks and hold vendor management responsibilities.

KEY ROLE AND RESPONSIBILITIES:

• Develop and distribute meeting agendas, minutes and monthly status reports to document key project updates and communications to relevant stakeholders, as requested. Support Clinical Trial Management in communication to CRO, Vendors and Investigator Sites.
• Support the Clinical Trial Manager with study start-up activities, to include preparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines, study logs and forms Site Contracts and Budgets, Vendor Contracts and Budgets, etc.).
• Support the Clinical Trial Manager in the tracking of subject recruitment at all study sites; monitoring visits and approval; infringements, breaches, and misconduct, fraud, and negative trends and protocol deviations. Notify CRO and sites of updates on global study information.
• Assist project team in the collection, review and filing of site Essential Documents, and maintenance of the TMF. Assist in the tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC and CTMS. 
• Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies. Support the Clinical Trial Manager in formal risk assessment activities; review and corrective action plans across study, participates in the planning of quality assurance activities, internal and external audits/inspections, and coordinates communication of audit/inspection findings.
• Participate in regular team meeting / teleconferences; CRO, Vendor and Investigator Site meetings as necessary; and Investigator Meetings, as necessary.
• Communicate any out-of-scope issues to the Clinical Trial Manager as soon as identified.
• Communication and support Clinical Trial Manager with cross-functional study team interaction.
• Other duties as assigned.

 PREFERRED EDUCATION:

• BSc in in biomedical sciences or related scientific discipline with 2 years clinical research experience.

 PREFERRED EXPERIENCE:

• Demonstrated experience operating effectively in a clinical environment
• Experience working with clinical protocols

KNOWLEDGE, SKILLS AND ABILITIES:

• Excellent verbal and written communication skills required.
• Excellent organizational, multi-tasking and time management skills required.
• Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines

Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.

The salary range for this position is $34.62 to $43.27 hourly, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.

 

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.