YCCI Clinical Research Associate [Monitor]

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Overview

The Clinical Research Associate [Monitor] will be responsible for independently performing site monitoring activities to ensure that sites are conducting and reporting the clinical trials in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and applicable regulatory requirements.  

Frequent onsite travel is required. This position will be partially funded by the sponsored awards it supports.  

Essential Duties of the Position  

1. Reports directly to the monitoring manager of YCCI and works collaboratively with YCCI cross-functional services, sponsors, site teams, HRPP and the IRB to facilitate the review of the activities associated with human subjects research in terms of safety, compliance, and integrity of clinical trials conducted at the Yale School of Medicine, Yale New Haven Hospitals and external (non-Yale) sites.  

2. Conducts site monitoring activities, including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Close Out Visits per protocol specific monitoring plans.  

3. Review medical records, source documentation, and electronic data capture systems to verify data accuracy, completeness, and compliance with ALCOA principles 

4. Identifies research non-compliance issues, determines the impact on study plans/processes, exercises judgment in the assessment of the level of risk associated with issues in terms of the need for reporting the leadership within YCCI, Departmental leadership, HRPP and the IRB and/or other regulatory entities.   

5. Provides direction to the site teams to improve research performance and ensure regulatory compliance.  

6. Assesses the risk and stratifies the clinical trials from a QA/regulatory compliance perspective based on clinical research experience and regulatory knowledge.  

7. Creates and maintains appropriate monitoring documentation. Reviews monitoring visit findings with the site investigators and research staff and follow up on the action plans.  

8. Stay abreast of federal and state regulatory updates and emerging guidance. Interpret and apply new requirements to ensure institutional compliance. 

9. Performs additional duties as assigned. 

Required Qualifications 

1. Bachelor's degree in a scientific or healthcare-related field 

2. Minimum of two years of working experience in clinical research 

3. Understanding of clinical research review, approval and Data and Safety Monitoring processes.  

4. Knowledge of ICH-GCP requirements and regulatory requirements 

5. Completion of GCP training within 3 months of hire. 

6. Knowledge of federal regulations concerning the protection of human subjects and clinical trial design, implementation and analysis.  

Required Skills and Abilities

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

2. Ability to work independently - planning, prioritizing, and executing projects with minimal supervision. 

3. Strong organizational skills and the ability to manage multiple/diverse projects simultaneously.  

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

5. Demonstrates understanding of clinical research processes and procedures from start-up to close out.  

6. Adaptability to evolving technologies and processes.

Preferred Education and Experience

1. SOCRA/ACRP (or equivalent) certification  

2. Master’s Degree or other advanced degree in related field  

3. Experience with remote and onsite monitoring approaches. 

4. Familiarity with multiple therapeutic areas. 

Principal Responsibilities

1. Works directly and in collaboration with YCCI leadership, Departmental leaders, investigators, research staff, HRPP and the IRB to facilitate the review the activities associated with human subject research in terms of safety, compliance, and integrity of clinical trials conducted at Yale and at collaborating institutions. 2. Evaluates clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and Guidelines to Good Clinical Practice. 3. Identifies research non-compliance and reports