The Clinical Trial Associate will be responsible for ensuring site compliance with protocol and regulatory requirements. He/she will provide support to the Clinical Trial Manager in any activities related to the management of sites and CRO(s).
This role is based in Menlo Park, California, and will move to Sunnyvale, California in Fall 2026. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 40% requirement for the site. At our Menlo Park campus, Tuesdays and Thursdays are the key days where we encourage on-site presence to engage in events and on-site activities.
Responsibilities:
Acts as an internal contact for sites and will triage any issue escalation as appropriate
Ensure study staff receive appropriate training and proper materials.
Assists and prepare any study related plans and documents
Ensure all required essential documents are collected from sites during study initiation and throughout the duration of the studies.
Proactively identify site related issues and address appropriately with CTM guidance
Independently create project specific tools and documents (e.g. meeting materials, tracking spreadsheets, training tools/materials) to support site management.
Provide overall TMF oversight and conduct TMF QC of the sites being managed
Review and reconcile site invoices for site payments
Assist in training of Clinical Project Assistants.
Support CTM in any assigned tasks
Under the general supervision and guidance, may participate in departmental strategic initiatives.
Required Qualifications:
Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework in clinical trial planning and execution is strongly desired.
Ideal candidate will have at least 3 years of relevant experience in managing clinical trials at a sponsor company (pharma, biotech, or medical device) with a strong track record of successful trial initiation and execution.
Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable.
Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
Working experience with an electronic data capture system, CTMS system, and eTMF system.
Proficient with office automation tools, such as Microsoft Office and the Google suite of apps.
Preferred Qualifications:
Excellent organizational and time management skills with the ability to manage multiple priorities.
Strong written and verbal communication skills, including business correspondence.
Ability to work independently with limited supervision and make routine decisions within defined parameters.
Strong problem-solving skills and resourcefulness in addressing administrative challenges.
Professional demeanor with strong interpersonal skills to work effectively across the organization.
High attention to detail and accuracy.
Able to work effectively under a fast-paced and changing environment.
Strong work ethic and demonstrated ability to deliver assignments on time.
Physical Demands and Work Environment:
Standard office environment with extended periods of computer and desk work.
Frequent interaction with employees at all levels, as well as vendors and external stakeholders.
Occasional lifting of office supplies or materials (up to 20 lbs).
Regular business hours with occasional overtime to support meetings, travel, or special events.
GRAIL Menlo Park, California, USA Office
GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. We also have a number of employees who are working remotely. Our bay area office has a employees working in our labs, software engineering, clinical development and more.
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