Clinical Research Analyst

Required Skills and Abilities: Demonstrated experience and understanding with IRB protocols and submissions. Professional verbal and written communication skills. Capacity for knowledge sharing and ability to communicate complex ideas across cross-functional teams. Proficient computer skills. Working knowledge of Microsoft Office suite. Ability and desire to learn new computer platforms and software programs. Solution-oriented with ability to work independently. Able to prioritize tasks with competing deadlines and minimal supervision. Maintains attention to detail in a fast-paced team environment with strong organizational and time management abilities. Ability to manage multiple concurrent projects while balancing priorities and timelines.

Preferred Skills and Abilities: Demonstrated experience supporting Oncology department. Demonstrated experience as a clinical research analyst supporting regulatory affairs.

Principal Responsibilities: Works closely with investigators and other study team members including the project manager, for projects or programs of a small size or sections of medium projects and programs to consult, conduct analysis, and identify trial objectives and requirements within specific parameters. Interprets research business needs and translates them into application and operational requirements for a specific area(s) of research. Develops necessary tools and workshops to successfully elicit requirements. Critically evaluates information gathered from multiple sources – research protocols, clinical trial agreements, financial budgets and fees associated with research - to reconcile conflicts, and decompose high-level information into data essentials. Analyzes data with standard methods, interprets the results, and provides written summary and reporting of data analysis. Develops reporting modules, ad-hoc reports and related reporting tools. Conducts research, data analysis, modeling, projecting and scenario analyses, with the aid of planning technology and databases. Develops and maintain documentation and libraries on key processes. Assesses risk and ensures compliance with research protocols/guidelines, university procedures, and third party regulations. Determines training needs, designs, develops and conducts training sessions, meetings and conference calls with study teams and staff members. Performs or assists with research compliance audits or self-assessments. Communicates effectively the perspective of business opportunities, needs, and risks.

Required Education and Experience: Bachelor's degree in a related field and one year of related work experience in the same job family or an equivalent combination of experience and education. Must be knowledgeable in regional and federal regulations with the ability to perform independent decision-making on a daily basis.