YCCI Clinical Research Associate; Monitor

Location

2 Church Street South, New Haven, Connecticut

$68,000.00 - $

Reporting to the Senior Manager of Monitoring for YCCI, the incumbent conducts clinical research monitoring for clinical trials conducted at the Yale School of Medicine and external (non-Yale) sites. The Clinical Research Associate will be responsible for independently tracking, planning, ensuring the research activities are conducted in accordance with 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. This position will be partially funded by the sponsored awards it supports.

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. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure compliance. May perform other duties as assigned.

• 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.
• Advanced interpersonal, oral and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders.

• SOCRA/ACRP (or equivalent) certification
• Master’s Degree or other advanced degree in related field