Research Associate 2

Research Associate

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Overview

In the Department of Pediatrics, these research studies focus primarily on aortic disease and the associated genetic conditions. The Research Associate initiates and conducts protocol review, evaluations, study design and risk assessments of clinical research studies. Responsible for developing informational materials for the recruitment of subjects, monitoring enrollment goals, and modifying recruitment strategy as needed. Identifies and selects potential subjects, screens subjects, enrolls subjects, performs subject interviews and assessments for data as required by protocol(s), and collects and manages subjects data and biospecimens. The Research Associate oversees and ensures compliance with regulations, prepares and submits IRB documents and prepares regulatory documents for the sponsor. Additional responsibilities include review of incoming subject adverse event (SAE) information, assisting the PI in making submission determination of SAEs and follow up to determine resolution of adverse events. The position also conducts study-related non-medical/behavioral assessments/interventions and is responsible for records, documents and reports on protocol deviations and trial changes to the PI and sub-investigators. Must stay up to date on knowledge of regulatory affairs. Ensures that key personnel are compliant with Conflict of Interest, Human Subject, Animal, Safety, HIPAA and other training mandates. Ensures the timely and accurate entry of sponsored award data into the University's electronic data tracking systems (GPAS, INFOED or other similar systems). May perform other duties as assigned.

Required Skills and Abilities

1. Experience with regulatory and Institutional Review Board (IRB) processes, protocol development, and all phases of clinical research, including study coordination, data management, and analysis.

2. Excellent written and verbal communication skills with strong attention to detail, sound judgment, and the ability to identify and resolve problems effectively.

3. Strong organizational, time management, and multitasking skills, with the ability to prioritize competing responsibilities and maintain a high level of quality.

4. Demonstrated ability to work independently while collaborating effectively as part of a multidisciplinary team.

5. Proficiency in Microsoft Office Suite and experience using electronic data collection and clinical research management systems.

Principal Responsibilities

1. Carries out research within the scope of the established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies. 2. Develops criteria for admission of study subjects based on goals and objectives of project. 3. Determines potential sources of funding and prospective partnerships. 4. Evaluates feasibility of accepting potential projects through analysis of staffing needs, resource requirements, financial costs, and current planned capacity of group. Negotiates contracts and/or changes with funder. 5. Develops original HIC/IRB submissions. Based on knowledge of science and research goals, collaborates with PIs on major revisions and contributes to scientific protocols. Plans and implements changes. 6. Develops forms, questionnaires and the application of research techniques; writes procedures manuals for data collection and coding. 7. Responsible for the documentation and transmission of study data. Ensures that report forms are accurately documented and completed in a timely manner at each site location. 8. Works independently to develop manage and organize multi site studies. Serves as primary coordinator between University, non-Yale collaborators, pharmaceutical companies, HIC, IRB and funding sources. 9. Performs descriptive and multivariate statistical analyses of data, using computer software. 10. Designs and implements quality control measures to ensure accurate collection and processing of data. 11. Contributes in-depth, original thought and relevance to written reports and to the writing of abstracts and manuscripts.

Required Education and Experience

Master's Degree in a related discipline and two years of experience or an equivalent combination of education and experience.