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Senior Clinical Trials Associate

Trident Consulting

Aliso Viejo, CA

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JOB DETAILS
SALARY
SKILLS
Adverse Events, Analysis Skills, Auditing, Best Practices, Biotech and Pharmaceutical, Clinical Data, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Communication Skills, Consulting, Continuous Improvement, Corrective Action, Cross-Functional, Data Analysis, Data Cleaning, Data Quality, Decision Support, Document Control, Documentation, External Audit, FDA Requirements, File Audits, File Management, Financial Analysis, GCP (Good Clinical Practices), IP (Internet Protocol), Internal Audit, Investigational New Drug (IND), Leadership, Logistics, Maintain Compliance, Medical Equipment, Mentoring, Multitasking, Operational Strategy, Operations Processes, Ophthalmology, Organizational Skills, People Management, Performance Metrics, Problem Solving Skills, Process Development, Process Improvement, Program Evaluation, Reconciliation, Regulations, Regulatory Requirements, Risk Analysis, Site Initiation, Startup, Systems Maintenance, Team Lead/Manager, Trend Analysis
LOCATION
Aliso Viejo, CA
POSTED
11 days ago
Trident Consulting is seeking a " Clinical Trials Associate” for one of our clients in "Aliso Viejo, CA (Hybrid)” — a global leader in Medical devices and pharmaceutical industry.

Job Title: Clinical Trials Associate
Location: Aliso Viejo, CA (Hybrid)
Type: Contract
Rate: $78/Hr on w2

Required Experience & Attributes
  • Prior Clinical Trials Associate (CTA) experience; not an entry-level opportunity.
  • Able to thrive in a fast-paced environment while managing multiple priorities.
  • Works independently after an initial training period (approximately the first three months).
  • Learns quickly and can ramp up efficiently.
  • Mature, proactive, and adaptable.
  • Comfortable asking questions, speaking up about issues, and communicating effectively with the team.
  • Flexibility and resilience are more important than direct ophthalmology experience.
  • The organization is currently experiencing several personnel changes, so flexibility is essential.
  • The role is best suited for someone who embraces change rather than someone who prefers a highly structured environment.
  • Maturity, professionalism, and strong communication will outweigh therapeutic area experience in many cases.

Job Details
The Sr. Clinical Trials Associate II is responsible for the advanced coordination and execution of clinical research studies in compliance with U.S. and international regulatory requirements, operating with a high degree of independence. This role serves as a key contributor to study strategy and execution, influencing protocol development, data integrity, and operational effectiveness across clinical programs. The position requires deep expertise in clinical trial processes, strong analytical capabilities, and the ability to proactively identify risks, resolve complex issues, and drive study deliverables with minimal oversight.

Requirements
Clinical Trials Leadership and Coordination
  • Serve as a core contributor to the development and refinement of clinical trial protocols and study documentation
  • Lead coordination of clinical study activities across multiple sites and stakeholders
  • Provide subject matter expertise to improve study execution and operational processes
  • Independently manage site communications and ensure alignment with study timelines and objectives
  • Deliver advanced analysis and interpretation of study data to support decision-making Clinical Data Review and Oversight
  • Perform in-depth review and analysis of complex clinical data from investigative sites
  • Identify systemic data trends, risks, and discrepancies; recommend and implement corrective actions
  • Lead data cleaning efforts and ensure data integrity across assigned studies
  • Provide guidance to junior team members on data review processes and best practices Study Master File (SMF) Strategy and Management
  • Oversee the establishment, maintenance, and continuous improvement of Study Master Files
  • Ensure completeness, quality, and audit readiness of all study documentation
  • Implement process improvements to enhance document control and tracking efficiency
  • Provide leadership-level reporting on SMF status, risks, and compliance Site Start-Up and Study Execution
  • Lead collection and quality review of site start-up documentation
  • Oversee preparation and distribution of regulatory binders for Site Initiation Visits (SIVs)
  • Drive resolution of site documentation issues and ensure regulatory compliance
  • Partner with CRAs to ensure readiness for monitoring visits and audits Trial Tracking and Operational Excellence Design and maintain advanced tracking systems for critical trial information, including:
  • Site performance and activation metrics
  • Enrollment and retention trends
  • Adverse event tracking and escalation
  • Site payments and financial reconciliation Analyze tracking data to identify operational risks and recommend solutions
  • Team Leadership and Cross-Functional Support
  • Lead internal and external meetings, including investigator site interactions
  • Provide mentorship and guidance to less experienced CTAs
  • Perform co-monitoring activities and support CRA development
  • Play a key role in internal and external audits and regulatory inspections
  • Coordinate complex study logistics, including investigational product (IP) supply and site support
  • Contribute to continuous improvement initiatives across clinical operations
  • 8+ years of experience as a Clinical Trials Associate, preferably within the ophthalmic field
  • Demonstrated advanced expertise in clinical trial execution, including study start-up, conduct, and close-out
  • Strong working knowledge of GCP, FDA, and international regulatory requirements
  • Proven ability to independently manage multiple studies or complex components of larger programs
  • Demonstrated experience leading data review, data cleaning, and issue resolution activities
  • Expertise in Study Master File management and audit/inspection readiness
  • Ability to identify process gaps and proactively implement improvements
  • Experience leading meetings, influencing stakeholders, and mentoring junior staff
  • May serve as a subject matter expert in systems, processes, or regulatory areas
  • Strong analytical, organizational, and problem-solving skills with the ability to work with minimal supervision

About the Company

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Trident Consulting

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