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Sr. Clinical Trials Associate II

HonorVet Technologies

Aliso Viejo, CA

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JOB DETAILS
SALARY
$62.64–$78.34 Per Hour
SKILLS
Adverse Events, Analysis Skills, Auditing, Best Practices, Biology, Biotech and Pharmaceutical, Clinical Data, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Consulting, Continuous Improvement, Contract Research Organization (CRO), Corrective Action, Cross-Functional, Customer Satisfaction, 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, Manufacturing, Medical Affairs, Medical Equipment, Mentoring, Operational Strategy, Operations Processes, Ophthalmology, Organizational Skills, People Management, Performance Metrics, Pharmacovigilance, Problem Solving Skills, Process Development, Process Improvement, Program Evaluation, Quality Assurance, Quality Control, Reconciliation, Regulations, Regulatory Requirements, Research Laboratory, Risk Analysis, Site Initiation, Staff Requirements, Startup, Systems Maintenance, Team Lead/Manager, Trend Analysis
LOCATION
Aliso Viejo, CA
POSTED
1 day ago
HonorVet Technologies (SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States. With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations. Our dedicated recruitment team focuses on delivering qualified life sciences and pharmaceutical professionals efficiently while ensuring quality, compliance, and client satisfaction.

Job Title: Sr. Clinical Trials Associate II
Job Location: Aliso Viejo, CA
Job Duration: 06 Months

Description:
  • 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

H

HonorVet Technologies

 Is a leading Service Disabled Veteran Owned Small Business providing IT, Telecom and Medical Staffing.

COMPANY SIZE
50 to 99 employees
INDUSTRY
Staffing/Employment Agencies
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2015
WEBSITE
http://www.honorvettech.com

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