Clinical Research Associate 2, HSS

at  Yale University

POSITION FOCUS:

RA will be working on different clinical trials for the PI that include screening, consent, blood draws, hemodynamic monitoring, processing of blood draws as specified in protocols, and follow ups. Study protocol may involve processing of blood samples as well as handling and shipment procedures. For additional study specific procedures and educational interventions, RA will be trained in the study protocols before execution.
We are seeking a candidate with excellent communication skills and a high degree of independence to join our team as a clinical research coordinator. Our lab conducts a combination of federally and industry funded studies. In this role, the research associate will assist the PI and Co-Investigators in implementing and coordinating various aspects of research projects, including patient screening and enrollment, data collection, and report preparation. Additionally, RA may be assigned other duties as needed.
The RA will be responsible for recruiting study participants and ensuring that subject recruitment and follow-up are completed per protocol procedures. This includes conducting screening, obtaining consent, performing blood draws, monitoring study procedures, and ensuring adherence to study intervention protocols.
Meticulous and accurate data management is essential for this role. The RA will be tasked with recording and compiling research data according to specifications, performing data collection and entry, and utilizing computer terminals to input, retrieve, and generate reports.
Furthermore, the RA will provide overall team support on all research projects, including data collection, analyses, and reporting. This includes processing and summarizing data using scientific or statistical techniques and assisting in the preparation of slides, posters, abstracts, and manuscripts.
Additional responsibilities include ordering and maintaining inventory of supplies and assisting in designing, developing, and modifying research experiments, procedures, or survey instruments under the supervision of the PI. The RA may also assist research and support staff as needed.
The ideal candidate may also assist in preparing institutional review board protocols, amendments, and annual reporting for departmental research.
This role requires flexibility and adaptability, as the RA will perform additional functions incidental to research activities of the team as required.

REQUIRED EDUCATION AND EXPERIENCE

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

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. 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, EXPERIENCE AND SKILLS:

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.

BACKGROUND CHECK REQUIREMENTS

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. All offers are contingent upon the successful completion of the background check. 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 It’s Your Yale website.

POSTING DISCLAIMER

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.

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.