The Study Start-Up Specialist (SSUS) plays a pivotal role in supporting timely site activation and regulatory readiness across assigned clinical studies. This role is responsible for managing site start-up activities, coordinating IRB submissions, and ensuring essential documentation is complete, accurate, and inspection ready. The Specialist works cross-functionally with project management, all Clinical Operations functions, QA, CRAs, and Sponsors to enable efficient study start-up and reduce downstream operational risk.

Essential Duties and Responsibilities

Regulatory Compliance

• Prepare, compile, and submit clinical trial applications to ethics committees, as applicable.

• Assemble and maintain submission dossiers, including managing responses to ethics committee queries

• Track submission timelines and approval status using applicable tools and internal trackers.

• Coordinate customization and site-specific adaptations of informed consent forms (ICFs) and patient information sheets.

Site Start Up & Activation

• Develop and execute detailed, study-specific start-up plans for assigned sites.

• Track site activation milestones and timelines using study-specific tools and trackers.

• Create, collect, review, and track essential documents for site activation.

• Ensure start-up documents are complete, compliant, and inspection ready.

• Identify risks to activation timelines and proactively escalate to study leadership.

• Schedule and coordinate start up meetings, including agendas and minutes as needed.

Contracts, Budgets & Cross Functional Collaboration

• Participate in site contract and budget discussions in collaboration with Contracts and Finance teams.

• Partner closely with CRAs/CTMs/PMs to ensure consistent and aligned communication with sites during the start-up phase.

• Serve as a primary point of contact for sites during start-up, providing clear guidance on expectations and timelines.

• Collaborate with internal stakeholders to resolve start-up issues and maintain momentum toward activation.

Documentation and Quality

• Maintain accurate, up-to-date documentation for the TMF and applicable study systems.

• Ensure compliance with protocol, SOPs, GCP, and applicable regulatory requirements, as well as study trackers.

• Support internal reviews, audits, and inspections related to start-up and regulatory activities.

• Assist continuous improvement of start-up and site activation processes.

• Assist with preparation of internal and sponsor-facing status reports

Feasibility and Site Tracking

• Support feasibility activities by tracking site level information, including:

  • Securing NDA/CDA from a site prior to sending study related materials

  • PI and site experience

  • Rater availability and experience

  • Patient population access

  • Competitive trial landscape.

• Maintain feasibility trackers; update site intelligence based on outreach, assessments, and site feedback.

• Assist in evaluating site readiness and capacity to support enrollment goals.

• Provide feasibility insights to CTMs, CRAs, and  project management as requested.

Audit and Inspection Readiness

• Ensure start-up documentation is inspection-ready at all times.

• Support internal TMF reviews and quality checks, addressing gaps in collaboration with CRAs and study teams.

• Assist with preparation for sponsor auditsand internal quality reviews.

• Respond to audit findings and support CAPA development related to start-up or regulatory processes.

• Ensure traceability between IRB submissions, approvals, and site activation documentation.

Perform other duties as assigned in support of departmental needs.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or related field (or equivalent education, training and experience).

• Two years of experience in clinical research, , site start-up, or clinical operations, or an equivalent combination of education and experience.  Preferrably with some CRO experience.

• Experience and knowledge of clinical start up process and requirements.

• Working knowledge of psychological assessments preferred.

• Working knowledge of clinical research regulations, including ICH-GCP and CFR.

• Ability to work independently with minimal supervision.

• Strong organizational skills and team player.

• Able to multitask and prioritize high workloads across multiple sites.

• Strong computer skills including but not limited to proficiency with Microsoft Office (Word, Outlook, and PowerPoint) and project management software (i.e., Monday.com); proficiency with Excel (e.g., creating and managing formulas; use of macros, pivot tables, and v-lookup; etc.)

• Strong written and verbal communication skills; ability to communicate effectively with a wide variety of stakeholders in a professional manner via different means of communication (i.e., face to face, on the telephone, email, etc.).

• Strong interpersonal skills with the ability to work with all levels of management and employees; ability to gain credibility, provide effective customer service, and foster positive working relationships with internal and external stakeholders

• Excellent attention to detail, including problem solving and decision-making skills

• Able to work accurately to identify, analyze, prevent, and solve issues.

• Ability to travel <10%