Feasibility & Study Start-Up Specialist

Job Title: Feasibility & Study Start-Up Specialist

Work Location: Santa Clara County, California

Summary:

Seeking a skilled professional to lead feasibility assessments and manage the start-up process for clinical research sites, with a focus on CNS/psychiatry trials. This role involves coordinating regulatory submissions, document management, and ensuring inspection readiness from the outset.

Responsibilities:

• Conduct feasibility assessments at both country and site levels, evaluating enrollment history and standard-of-care data to recommend optimal sites for clinical trials.
• Oversee the complete site start-up process, including essential document collection, contract and budget support, and regulatory submissions to meet activation deadlines.
• Monitor and manage the timeline to site activation and first patient enrollment, proactively identifying and escalating risks as needed.
• Coordinate submissions and approvals with regulatory authorities and ethics committees to ensure compliance with all requirements.
• Collaborate closely with clinical research associates and trial managers to ensure a seamless transition from site activation to monitoring phases.
• Maintain up-to-date trackers and documentation to support project transparency and timely decision-making.
• Implement processes to ensure all essential documents and trial master files are audit-ready from the start of site activation.
• Support inspection readiness and compliance by maintaining high standards in document management and regulatory practices.

Qualifications:

• Minimum 3 years of experience in clinical site start-up and/or feasibility, preferably within a clinical research organization or sponsor environment.
• Strong knowledge of ICH-GCP guidelines and regulatory/IRB submission requirements in the US and/or UK/EU.
• Demonstrated success in activating sites under tight timelines, with expertise in document management and clinical trial management systems (CTMS).
• Excellent organizational and communication skills, with the ability to thrive in a fast-paced, deadline-driven environment.
• Experience with CNS, psychiatry, or depression clinical trials is highly desirable.
• Background in multi-country start-up processes, including familiarity with UK HRA/MHRA procedures, is preferred.
• Proficiency with CTMS/eTMF systems and site-activation tracking tools (such as Veeva Vault) is advantageous.

Published Category: Clinical Operations & Development