REMOTE Clinical Research Monitor(CRA)

th approved protocols and reporting monitoring activities. The monitoring activities performed include but are not limited to: Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close Out Visits per protocol specific monitoring plans. Frequent travel, beyond CT, is required. Reporting directly to the Senior Manager of Monitoring for YCCI, works directly and in collaboration with YCCI leadership, Departmental leaders, investigators, research staff, HRPP and the IRB to facilitate the review of activities associated with human subjects research in terms of safety, compliance, and integrity of clinical trials conducted at Yale and at collaborating external institutions. Performs site qualification visits to determine the feasibility and appropriateness of a potential site before site selection. Monitors clinical trial data and regulatory documents per the protocol specific monitoring plan on-site and remotely to ensure research integrity and compliance with the IRB approved protocol, institutional policies, state and federal regulations, and ICH Good Clinical Practice. Reviews medical records of study participants, determines the impact of non-compliance (e.g. violations of federal regulations, GCP and University policies) on study plans/processes, makes judgments and communicates findings to investigators. Identifies research non-compliance and ensures reporting to appropriate leadership within YCCI, Departmental leadership, HRPP and the IRB. Exercises judgment in the assessment of the level of risk associated with findings in terms of the need for reporting out to other regulatory entities. Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance. Assesses the risk and stratifies the study from a QA/regulatory compliance perspective based on clinical research experience and regulatory knowledge. Reviews findings from monitoring visits with investigators and research staff and advises and monitors appropriate action plans. Monitors federal and state regulations for new guidance, updates, or policies. Advanced knowledge of monitoring techniques and practices. Demonstrable understanding of clinical research processes and procedures from study start-up to study close out. Comprehensive knowledge of federal regulations concerning the protection of human subjects and clinical trial design, implementation and analysis.

Comprehensive understanding of clinical research review, approval and Data and Safety Monitoring processes.

Professionalism, maturity, good judgment, and ability to work with confidential material and protected health information.

Self-directed with the ability to work, plan, research, and conduct projects with minimal supervision and on a flexible schedule. Organized and capable of handling multiple/diverse projects simultaneously.

Master’s Degree or other advanced degree in related field

Works directly and in collaboration with YCCI leadership, Departmental leaders, investigators, research staff, HRPP and the IRB to facilitate the review of activities associated with human subject research in terms of safety, compliance, and integrity of clinical trials conducted at Yale and at collaborating institutions.

Evaluates clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and Guidelines to Good Clinical Practice.

Identifies research non-compliance and reports to appropriate leadership within YCCI, Departmental leadership, HRPP, the IRB and the OGC.

Serves as liaison between the investigator, the research team and the FDA during an actual inspection. Consults to investigators needing data safety monitoring plan details/information for their grant application. Develops Data and Safety Monitoring Plans based on the risk assignment categories.

Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance.

Assesses the risk and stratify the study from a QA/regulatory compliance perspective based on clinical research experience and regulatory knowledge.

Reviews medical records of study participants, determines the impact of non-compliance (e.g. violations of federal regulations, GCP and University policies) on study plans/processes, makes judgments and communicates findings to investigators. Exercises judgment in the assessment of the level of risk associated with findings in terms of the need for reporting out to other regulatory entities.

Reviews reports/findings from audits with investigators and advises and monitors appropriate action plan.

Designs and conducts training programs, makes recommendations for quality improvement and assists in the creation and follow up of corrective action plans based on audit findings. Develops and delivers education and training programs to promote safety and compliance for the PI's and all study team members.

Conducts continuous auditing activities identifying areas of high risk and creates activity reports for ongoing analysis from a medical standpoint. Identifies areas of concern or heightened medical risk to subjects, investigators, or the University.

Integration of Data Safety and Monitoring Plans and QA findings with committees and educational plans.

Bachelor Degree in related field and five years of related experience or an equivalent combination of education and experience. GCP training required within 3 months of hire.

Bargaining Unit
Administration & Operations

Full time

Remote

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the Its Your Yale website.

Health Requirements
Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy.

The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.

Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).