Sr CRA

About the role

This fully home-based position performs and coordinates all aspects of clinical monitoring and site management for diverse clinical trials. The Senior Clinical Research Associate (Sr CRA) 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 the approved protocol, ICH-GCP guidelines, applicable regulations, and standard operating procedures to protect subjects’ rights and well-being and ensure data integrity.

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.

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.

Pay

The pay range for this position is $58.00 - $62.00/hr. 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 the following:

• 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)