Senior Clinical Research Associate

Multiple openings across the U.S. for a fully remote, W2 hourly position with door-to-door pay and exposure to diverse therapeutic areas.

About the role

The Senior Clinical Research Associate (Sr CRA) performs and coordinates all aspects of clinical monitoring and site management for diverse clinical trials. This role conducts remote and on-site visits to assess protocol and regulatory compliance, manages essential documentation, and oversees procedures and guidelines across various sponsor and monitoring environments, including FSO, FSP, and government settings. Acting as a site process specialist, the Sr CRA ensures trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures to protect subjects’ rights and well-being and ensure data integrity. The Sr CRA supports audit readiness, develops collaborative relationships with investigational sites, and contributes to continuous process improvement within the project team.

Responsibilities

• Perform and coordinate all aspects of clinical monitoring and site management across assigned clinical trials.
• Conduct remote and on-site monitoring visits to assess protocol adherence, regulatory compliance, and data quality.
• Apply a risk-based monitoring approach to investigator sites, using root cause analysis, critical thinking, and problem-solving skills to identify process failures and implement corrective and preventive actions.
• Ensure data accuracy and integrity through source data review (SDR), source data verification (SDV), and case report form (CRF) review during on-site and remote monitoring activities.
• Assess investigational product accountability through physical inventory checks and records review at investigator sites.
• Document monitoring observations in reports and correspondence using approved business writing standards and submit them in a timely manner.
• Escalate observed deficiencies, protocol deviations, and compliance issues to clinical management promptly and track all issues through to resolution.
• Maintain regular contact with investigative sites between monitoring visits to confirm protocol compliance, follow up on previously identified issues, and ensure timely data entry and query resolution.
• Conduct monitoring activities in accordance with the approved monitoring plan and study-specific procedures.
• Participate in the investigator payment process, ensuring accurate tracking and timely processing according to study requirements.
• Collaborate with other project team members to resolve site issues and findings, maintaining study quality and compliance.
• Provide trial status tracking and progress updates to the Clinical Team Manager (CTM) as required.
• Update study systems, including the Clinical Trial Management System (CTMS), in line with agreed study conventions and timelines.
• Perform quality control checks of reports generated from CTMS or other study systems when required.
• Participate in investigator meetings as needed, supporting site staff training and study start-up activities.
• Identify potential investigators in collaboration with the sponsor to evaluate and recommend qualified investigational sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with protocols, regulatory requirements, and ICH-GCP obligations, and make recommendations where warranted.
• Ensure proper trial closeout, including completion of required activities and retrieval of trial materials and documentation.
• Verify that essential documents are complete, accurate, and filed in accordance with ICH-GCP and applicable regulations.
• Conduct on-site file reviews as specified by the project to ensure completeness and regulatory compliance.
• Assist in the preparation of project publications, tools, and study-related materials, contributing ideas and suggestions to enhance project delivery.
• Support additional study tasks assigned by the CTM, such as reviewing trip reports, creating newsletters, and leading CRA team calls.
• Facilitate effective communication between investigative sites, the sponsor, and the project team through clear written, oral, and electronic communications.
• Respond to company, sponsor, and regulatory requirements, including audits and inspections, by providing documentation and clarifications as needed.
• Complete administrative tasks such as expense reports and timesheets accurately and within required timelines.
• Contribute to other project work and process improvement initiatives as required, sharing best practices and lessons learned.
• Maintain strong collaborative relationships with investigational sites to support high-quality trial conduct and site engagement.
• Ensure continuous audit readiness by maintaining up-to-date documentation and proactively addressing potential compliance gaps.

Requirements

• Bachelor’s degree in a life sciences-related field, a Registered Nursing certification, or an equivalent and relevant formal academic or vocational qualification.
• Previous experience equivalent to at least 2+ years as a clinical research monitor or Clinical Research Associate.
• Valid driver’s license where applicable.
• Effective clinical monitoring skills, including on-site and remote monitoring techniques.
• Demonstrated understanding of medical and therapeutic area concepts and medical terminology.
• Excellent understanding and practical application of ICH-GCP guidelines, applicable regulations, and procedural documents.
• Well-developed critical thinking skills, including a critical mindset, thorough investigation for root cause analysis, and effective problem-solving.
• Ability to manage and apply Risk Based Monitoring concepts and processes in day-to-day monitoring activities.
• Strong oral and written communication skills, with the ability to communicate effectively with investigators and other medical personnel.
• Ability to maintain a strong customer focus through active listening, attention to detail, and the ability to understand and address underlying site and sponsor needs.
• Effective interpersonal skills with the ability to build and maintain professional relationships with site staff and project team members.
• Strong attention to detail in all aspects of monitoring, documentation, and reporting.
• Effective organizational and time management skills, with the ability to handle multiple tasks and priorities.
• Ability to remain flexible and adaptable in a wide range of scenarios and changing project requirements.
• Ability to work effectively both independently and as part of a multidisciplinary team.
• Good computer skills, including proficient use of Microsoft Office applications and the ability to learn study-specific software and systems.
• Good English language and grammar skills, including the ability to prepare clear, concise, and professional documentation.
• Strong presentation skills, with the ability to contribute to meetings and training sessions.

Additional Qualifications

• Experience working with multiple sponsor types and monitoring environments, such as functional service outsourcing (FSO), functional service provider (FSP) models, and government-sponsored studies.
• Experience supporting diverse therapeutic areas within a global contract research organization or similar environment.
• Familiarity with Clinical Trial Management Systems (CTMS) and other electronic trial management tools.
• Experience participating in or supporting investigator meetings and site initiation visits.
• Experience contributing to project tools, publications, newsletters, or communication materials for clinical studies.
• Demonstrated ability to support audits and inspections by regulatory authorities or sponsors.
• Equivalency of education, training, and directly related experience may be considered in place of formal degree requirements, where appropriate.

Work Environment

This position is fully home-based, providing flexibility to work remotely while supporting clinical trials across multiple regions. The role requires frequent travel, typically in the range of 60% to 80%, to conduct on-site monitoring visits, site initiation, and closeout activities. Travel may include domestic and potentially international trips, depending on study assignments. Work is performed using standard office technology, including a computer, secure remote access to clinical systems, and communication tools such as email, web conferencing, and electronic trial management platforms. The environment is fast-paced and project-driven, with a strong focus on quality, compliance, and collaboration. Dress expectations typically align with professional business attire when visiting investigational sites or attending meetings, while home-based work allows for appropriate professional dress suitable for virtual interactions.

Pay

The pay range for this position is $58.00 - $62.00 per hour. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short- and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation, or Sick Leave)