Sr CRA I

Clinical Research Associate

The Clinical Research Associate performs and coordinates all aspects of clinical monitoring and site management for diverse clinical trials. This role conducts remote and on-site monitoring visits to assess protocol and regulatory compliance, manages essential documentation, and applies risk-based monitoring principles to ensure high-quality data and participant safety. The Sr CRA I acts as a site process specialist, ensuring that each trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and standard operating procedures, while maintaining audit readiness and fostering strong collaborative relationships with investigational sites.

Responsibilities

• Perform and coordinate all aspects of the clinical monitoring and site management process across multiple studies and sponsors.
• Conduct remote and on-site monitoring visits using a risk-based monitoring approach to assess protocol adherence, regulatory compliance, and overall site performance.
• Apply root cause analysis, critical thinking, and problem-solving skills to identify site process failures and define 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, as applicable, during on-site and remote monitoring activities.
• Assess investigational product accountability through physical inventory checks and records review, confirming proper storage, handling, and documentation.
• Document monitoring observations clearly and comprehensively in reports and follow-up letters, using approved business writing standards and submitting them in a timely manner.
• Escalate observed deficiencies, non-compliance issues, and risks to clinical management promptly, and track all issues through to documented resolution.
• Maintain regular communication with investigative sites between monitoring visits, as needed, to confirm protocol adherence, ensure timely data entry, and verify that previously identified issues are being resolved.
• Conduct all monitoring tasks in accordance with the approved monitoring plan and study-specific procedures.
• Participate in the investigator payment process, ensuring that payments are aligned with site performance and contractual terms.
• Share responsibility with other project team members for resolving study issues and findings, collaborating to maintain study quality and timelines.
• Provide trial status tracking and progress updates to the Clinical Team Manager (CTM) or equivalent, as required.
• Update study systems, such as the Clinical Trial Management System (CTMS), according to agreed study conventions, ensuring that information is accurate and current.
• Perform quality control checks of reports and outputs generated from CTMS or other systems, where required, to ensure completeness and accuracy.
• Participate in investigator meetings as needed, contributing to site training, protocol clarification, and study start-up activities.
• Identify potential investigators in collaboration with the sponsor to evaluate and recommend qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures, ensuring that each site is prepared, trained, and compliant with the protocol, ICH-GCP, and regulatory obligations.
• Ensure timely and compliant trial close-out at assigned sites, including retrieval of trial materials and verification that all essential documents and data are complete.
• Verify that required essential documents are complete, accurate, and appropriately filed in accordance with ICH-GCP and applicable regulations, including conducting on-site file reviews as per project specifications.
• Contribute to project teams by assisting with the preparation of project tools and publications, such as monitoring tools, study newsletters, and other trial-related materials.
• Perform additional study-related tasks as assigned by the CTM, which may include reviewing trip reports, supporting newsletter creation, and leading CRA team calls.
• Facilitate effective communication between investigative sites, the sponsor, and the project team through clear written, oral, and electronic communication.
• Respond to company, sponsor, and regulatory requirements, including participating in audits and inspections, and providing requested documentation and explanations.
• Complete administrative tasks, such as expense reports and timesheets, accurately and within required timelines.
• Contribute to process improvement initiatives and other project work aimed at enhancing operational efficiency and quality.
• Support clinical research in key therapeutic areas such as oncology and central nervous system (CNS) indications, applying relevant medical and therapeutic knowledge.

Essential Skills

• Bachelors degree in a life sciences-related field, a registered nursing qualification, or an equivalent and relevant formal academic or vocational qualification.
• Previous experience comparable to at least 2+ years as a clinical research monitor or Clinical Research Associate (CRA).
• Valid drivers license, where applicable, to support travel to investigative sites.
• Effective clinical monitoring skills, including on-site and remote monitoring of clinical trial sites.
• Demonstrated understanding of medical and therapeutic area knowledge, particularly in areas such as oncology and CNS, and strong familiarity with medical terminology.
• Excellent understanding and practical application of ICH-GCP guidelines, applicable regulations, and procedural documents in day-to-day monitoring activities.
• Proven ability to apply risk-based monitoring concepts and processes, including prioritizing critical data and processes.
• Well-developed critical thinking skills, including a critical mindset, in-depth investigation capability, and strong root cause analysis and problem-solving abilities.
• Strong oral and written communication skills, with the ability to communicate effectively with investigators, site staff, and medical personnel.
• Ability to maintain customer focus by using good listening skills, attention to detail, and the ability to identify and understand underlying site and sponsor needs.
• Strong interpersonal skills, with the ability to build and maintain collaborative relationships with investigational sites and project teams.
• High attention to detail in monitoring, documentation, and reporting activities.
• Effective organizational and time management skills, with the ability to manage multiple priorities and sites simultaneously.
• Ability to remain flexible and adaptable in a wide range of scenarios, including changing study requirements and timelines.
• Ability to work effectively both independently and as part of a cross-functional team.
• Good computer skills, including proficient use of Microsoft Office applications and the ability to learn and use clinical trial software systems such as CTMS.
• Good English language proficiency and grammar skills, with the ability to prepare clear, professional documentation and presentations.
• Experience with clinical research, clinical monitoring, and site monitoring in alignment with GCP standards.

Additional Skills & Qualifications

• Experience working within different sponsor models and monitoring environments, such as full-service outsourcing (FSO), functional service provider (FSP) arrangements, and government-sponsored trials.
• Familiarity with risk-based monitoring approaches, including the use of targeted SDR and SDV strategies.
• Experience in oncology and CNS clinical research studies, or other complex therapeutic areas.
• Ability to participate in and contribute to investigator meetings, including site training and protocol clarification.
• Experience identifying and evaluating potential investigative sites in collaboration with sponsors.
• Prior involvement in investigator payment processes and understanding of site financial workflows.
• Experience contributing to study tools and publications, such as monitoring tools, study newsletters, and internal guidance documents.
• Comfort responding to audits and inspections, including preparing documentation and addressing findings.
• Willingness to travel extensively to support site monitoring and management needs.
• In some cases, a combination of appropriate education, training, and directly related experience may be considered equivalent to formal academic requirements.

Work Environment

This position is a home-based role with a fully remote primary work setup, supported by extensive field travel to investigative sites. The role involves approximately 6080% travel, including an average of 810 overnight visits per month to conduct on-site monitoring and site management activities. Work is performed using standard office and clinical research technologies, including Microsoft Office applications and clinical trial management systems (CTMS). The environment requires frequent interaction with investigative sites, project teams, and sponsors via phone, email, and virtual meetings. Hours may vary based on site visit schedules, time zones, and study timelines, and flexibility is important to accommodate site needs and project deadlines. Dress expectations align with professional standards appropriate for virtual meetings and on-site visits to clinical and research facilities.

Job Type & Location

This is a Contract position based out of Denver, CO.

Pay and Benefits

The pay range for this position is $58.62 - $62.07/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills,