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HERC: Metro New York & Southern Connecticut Clinical Research Associate 2, HSS in New Haven, Connecticut

Employer Name: Yale University

  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 Skill/ability 1: Clinical Research Proficiency and Compliance: Proven experience with clinical studies. Conducts research within study protocols while adhering to human subjects regulations set by Yale University and federal government. Maintains compliance with all relevant regulations throughout the research process. Required Skill/ability 2: Self-Motivation, Organization, and Detail-Orientation: Demonstrates self-motivation, independence, consistency, and reliability. Shows excellent attendance, punctuality, and organizational skills. Pays close attention to detail and communicates effectively. Required Skill/ability 3: Effective Under Pressure with Communication and Leadership: Proven ability to work efficiently and independently under pressure, prioritizing tasks effectively. Demonstrates strong oral and written communication skills, along with leadership qualities. Required Skill/ability 4: Technical Proficiency in Research Tools: Exhibits proficiency in Microsoft Office, preferably Redcap, and statistical analysis software like SPSS. Proven experience with electronic data collection tools such as iPads and software like Endnote and Adobe. Required Skill/ability 5: Data Management and Quality Assurance: Responsible for documenting and transmitting study data per rigorous quality standards. Designs and implements quality control measures to ensure accurate collection and processing of data. Preferred Education: Proven experience conducting and supporting all phases of research in a clinical environment including data management and analyses. Experience preparing IRB protocols, amendments and progress reports. Independently develops, manages and organizes multi-site studies; serves as primary coordinator between University, non-Yale collaborators, pharmaceutical companies, HIC, IRB and funding sources. Work Week: Standard (M-F equal number of hours per day) Posting Position Title: Research Associate 2, HSS University Job Title: Clinical Research Associate 2, HSS Preferred Education, Experience and Skills: Proven experience conducting and supporting all phases of research in a clinical environment including data management and analyses. Experience preparing IRB protocols, amendments and progress reports. Independently develops, manages and organizes multi-site studies; serves as primary coordinator between University, non-Yale collaborators, pharmaceutical companies, HIC, IRB and funding sources. Master's Degree in a related discipline and two years of experience or an equivalent combination of education and experience.
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