Sr CRA II

Clinical Research Associate

This Clinical Research Associate II role focuses on performing and coordinating all aspects of clinical monitoring and site management across diverse studies and sponsors. You will conduct remote and on-site monitoring visits to assess protocol and regulatory compliance, manage essential documentation, and ensure that clinical trials are conducted in accordance with ICH-GCP guidelines, applicable regulations, and internal SOPs. Acting as a site process specialist, you will help safeguard participant rights and well-being, maintain data integrity, and support audit readiness while building strong, collaborative relationships with investigational sites.

Responsibilities:

• Perform and coordinate all aspects of clinical monitoring and site management for assigned studies, following applicable protocols, ICH-GCP guidelines, regulations, and SOPs.
• Conduct remote and on-site monitoring visits using a risk-based monitoring approach to assess protocol adherence, regulatory compliance, and data quality.
• Apply root cause analysis, critical thinking, and problem-solving skills to identify site process failures and implement corrective and preventive actions to bring sites into compliance and reduce risk.
• 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, ensuring proper storage, handling, and documentation.
• Document all monitoring observations clearly and accurately in reports and follow-up letters using approved business writing standards and submit them in a timely manner.
• Escalate identified deficiencies, issues, and risks to clinical management promptly and track all issues through to full resolution.
• Maintain regular contact with investigative sites between monitoring visits, as needed, to confirm ongoing protocol compliance, timely data entry, and resolution of previously identified issues.
• Conduct monitoring tasks in accordance with the approved monitoring plan and study-specific requirements.
• Participate in the investigator payment process by providing necessary site-level information and supporting documentation.
• Share responsibility with other project team members for issue and finding resolution, collaborating closely to ensure consistent site oversight.
• Provide trial status tracking and progress updates to the Clinical Team Manager (CTM) and other stakeholders as required.
• Update study systems, such as the Clinical Trial Management System (CTMS), in line with agreed study conventions and perform quality control checks of CTMS-generated reports when required.
• Participate in investigator meetings as needed, contributing to discussions on site performance, protocol requirements, and operational expectations.
• Identify potential investigators in collaboration with the sponsor to evaluate and recommend qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures, ensuring compliance with the protocol, regulatory requirements, and ICH-GCP obligations, and making recommendations where appropriate.
• Ensure proper trial close-out, including retrieval of trial materials and verification that all study and regulatory requirements are met.
• Verify that all required essential documents are complete, accurate, and in place according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews and perform regular checks of essential documents in line with project specifications.
• Contribute to the project team by assisting with the preparation of project publications, tools, and study-related materials, and by sharing ideas and suggestions for improvement.
• Perform additional study tasks as assigned by the CTM, such as reviewing trip reports, creating newsletters, or leading CRA team calls.
• Facilitate effective communication between investigative sites, the sponsor, and the project team through clear written, oral, and electronic interactions.
• Respond to company, sponsor, and regulatory requirements, including audits and inspections, by providing accurate documentation and supporting information.
• Complete administrative tasks such as expense reports and timesheets accurately and on time.
• Contribute to other project work and process improvement initiatives as required, supporting continuous improvement of monitoring practices.

Essential Skills:

• Bachelors degree in a life sciences-related field, Registered Nursing certification, or an equivalent and relevant formal academic or vocational qualification.
• Previous experience as a clinical research monitor, typically comparable to at least 2+ years of independent clinical monitoring experience.
• Valid drivers license where applicable to support required travel.
• Effective clinical monitoring skills, including experience with on-site and remote monitoring activities.
• 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 the ability to perform in-depth investigations, conduct appropriate root cause analyses, and implement effective problem-solving strategies.
• Ability to manage and apply Risk Based Monitoring concepts and processes in daily monitoring activities.
• Strong oral and written communication skills, with the ability to interact effectively with investigators, site staff, and other medical personnel.
• Ability to maintain strong customer focus through active listening, attention to detail, and the ability to identify and understand underlying site or sponsor issues.
• Effective interpersonal skills with the ability to build collaborative relationships with investigational sites and project teams.
• Strong attention to detail, ensuring accuracy and completeness in documentation and data review.
• Effective organizational and time management skills, with the ability to manage multiple priorities and deadlines.
• Ability to remain flexible and adaptable in a wide range of scenarios and changing project needs.
• Ability to work both independently and as part of a team, taking ownership of assigned tasks while collaborating with others.
• Good computer skills, including proficient use of Microsoft Office applications and the ability to learn and use clinical trial software and systems such as CTMS.
• Good command of the English language, including strong grammar and business writing skills.
• Confident presentation skills for participation in investigator meetings and internal team discussions.

Additional Skills & Qualifications:

• Experience working as a Clinical Research Associate (CRA) within a global or large-scale clinical research organization.
• Experience clinical research with exposure to central nervous system (CNS) and oncology therapeutic areas.
• Experience with site monitoring, including start-up, routine monitoring, and close-out visits.
• Familiarity with working under different sponsor models and monitoring environments, such as Functional Service Outsourcing (FSO), Functional Service Provider (FSP), and government-sponsored studies.
• Experience ensuring audit readiness and supporting regulatory inspections at investigational sites.
• Demonstrated ability to contribute to project publications, tools, and communications such as newsletters and team updates.
• Experience leading or actively participating in CRA team calls or cross-functional meetings.
• Comfort working within a contingent or contract-based role structure, supporting multiple projects as needed.
• Willingness to travel extensively to support on-site monitoring activities.

Work Environment:

This position is 100% home-based within the United States and involves frequent travel, typically ranging from 60% to 80%, to conduct on-site monitoring visits at investigational sites. You will work remotely using standard office technology, including a computer, secure clinical trial systems, and collaboration tools, and you will regularly use Microsoft Office applications and Clinical Trial Management Systems (CTMS). The role requires effective self-management in a home office setting, with flexibility to accommodate travel schedules, site visit timelines, and project deadlines. You will collaborate virtually with cross-functional project teams and site staff, and you will adapt to varying site environments and procedures while maintaining compliance with ICH-GCP and regulatory standards.