Clinical Trial Site Readiness & CRO Development Consultant

Location:  Southern California
Work Arrangement: Remote / Hybrid with onsite support as needed
Start: ASAP
Schedule: Variable based on project needs; approximately 30–40 hours per week anticipated
Travel: Onsite support in California as needed

Position Overview

We are seeking an experienced Clinical Trial Site Readiness & CRO Development Consultant to support a healthcare research organization preparing for near-term Phase I clinical trial activities while establishing the foundation for broader CRO capabilities.

The immediate priority is to conduct a comprehensive site-readiness gap assessment, identify critical compliance and operational gaps, and accelerate the development and implementation of SOPs, quality processes, and supporting infrastructure required for trial execution. The organization is working toward initiating trial activities by the end of Q4, requiring practical, risk-based support focused on the highest-priority readiness requirements.

The consultant will work closely with clinical, operational, quality, regulatory, and technology stakeholders to align site processes with Good Clinical Practice (GCP), safety reporting requirements, and technology supporting trial operations. The engagement may also include strategic guidance as the organization progressively expands from site-level trial execution toward broader CRO capabilities.

Key Responsibilities

• Conduct a comprehensive clinical trial site-readiness gap assessment of existing infrastructure, processes, documentation, and compliance controls.

• Identify and prioritize critical gaps that could affect near-term Phase I trial initiation and patient enrollment.

• Review existing SOPs and determine which procedures require creation, revision, or further implementation.

• Develop and refine GCP-aligned SOPs supporting clinical site operations, data and safety reporting, quality, and compliance activities.

• Ensure site-readiness activities appropriately address operational and compliance considerations associated with CNS and behavioral health clinical research.

• Establish a practical, risk-based roadmap for addressing readiness gaps and sequencing remediation activities.

• Support implementation of compliant adverse event (AE) and serious adverse event (SAE) reporting processes.

• Evaluate alignment between clinical trial SOPs and internal technology supporting functions such as dosing schedules, procedures, and safety reporting.

• Collaborate with clinical, operational, quality, regulatory, and technology stakeholders to ensure systems and procedures support compliant trial execution.

• Support staff training and implementation of newly developed or revised procedures.

• Assist with inspection readiness and preparation for mock regulatory inspections as the program progresses.

• Provide strategic guidance regarding the infrastructure, quality systems, SOPs, and compliance framework needed to progressively develop broader CRO capabilities.

• Identify operational and regulatory considerations associated with decentralized and virtual clinical trial models.

• Provide guidance, where applicable, on expanding capabilities to support medical device clinical trials.

• Advise on registry and real-world data infrastructure and processes supporting future real-world evidence activities.

• Coordinate with specialized consultants as needed across quality, regulatory, technology, clinical operations, and SOP-development workstreams.

Required Qualifications

• Significant experience in clinical research operations, clinical trial site readiness, CRO operations, quality, or regulatory compliance.

• CNS and behavioral health clinical research experience.

• Demonstrated experience conducting clinical research gap assessments and translating findings into actionable readiness plans.

• Strong knowledge of Good Clinical Practice (GCP) requirements and compliant clinical trial operations.

• Hands-on experience developing, reviewing, and implementing clinical research SOPs and supporting procedures.

• Experience establishing or evaluating clinical safety reporting processes, including AE and SAE reporting.

• Ability to assess operational and compliance processes and develop practical solutions supporting rapid trial readiness.

• Experience working cross-functionally with clinical, quality, regulatory, operational, and technology stakeholders.

• Ability to provide both strategic guidance and hands-on execution support.

Preferred Qualifications

• Experience supporting Phase I clinical trials.

• Experience developing or scaling CRO or site-management capabilities.

• Experience with decentralized, virtual, or hybrid clinical trial models.

• Medical device clinical trial experience.

• Experience with clinical research registries, real-world data, and/or real-world evidence programs.

• Experience evaluating or integrating technology platforms supporting clinical trial operations and compliance.

• Experience supporting regulatory inspection readiness and/or mock inspections.

Work Arrangement

The schedule and weekly time commitment will vary based on project needs and the phase of the engagement, with approximately 30–40 hours per week anticipated based on current needs. Initial gap assessment, SOP review, documentation development, and many compliance activities may be performed remotely.

Onsite support in California may be required for implementation, training, inspection-readiness activities, or other operational needs. California-based consultants are preferred when practical to facilitate onsite collaboration.

Ideal Candidate

The ideal consultant is an experienced clinical research operations and compliance professional with direct CNS and behavioral health clinical research experience who can quickly assess site readiness, prioritize critical gaps, and translate regulatory expectations into practical processes and SOPs. The strongest candidates will combine hands-on trial-readiness experience with the strategic perspective needed to help establish scalable clinical research and CRO infrastructure.