"Clinical Research Analyst"

Overview

The Clinical Research Analyst (CRA) applies research experience to support clinical research study teams, ensuring compliance with research regulations, policies, and procedures. Responsibilities include data management, analysis, and providing business understanding and analytics for various projects. The CRA will have direct patient contact to consent and recruit them and is involved in managing multiple research projects and supporting the analytical needs of several investigators. The CRA will help coordinate meetings with study teams and collaborators. The CRA will help with sample processing and data cleaning. The CRA will meet with the supervisor regularly to ensure key steps of projects are being executed on time.

Required Skills and Abilities

1. Excellent verbal and written communication skills with strong organizational and time management abilities.
2. Demonstrated experience with clinical research data management and compliance with regulatory documents.
3. Strong clinical and research skills, including knowledge of medical and research terminology and methodologies.
4. Ability to work independently, prioritize tasks with competing deadlines, and solve problems effectively.
5. Proficiency in data analysis using statistical software and flexible schedule availability.

Preferred Skills and Abilities

1. Bachelor's degree in a relevant field with experience in clinical research.
2. Ability to work with minimal supervision in a team environment and adapt to new processes.
3. Experience with clinical data management resources such as EPIC, OnCore, RedCAP, Excel, PowerPoint, NVivo, and R/other statistical software.
4. Familiarity with clinical research, rheumatic disease.

Principal Responsibilities

1. 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.
2. 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.
3. 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.
4. 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
5. Develops and maintain documentation and libraries on key processes.
6. Assesses risk and ensures compliance with research protocols/guidelines, university procedures, and third party regulations.
7. Determines training needs, designs, develops and conducts training sessions, meetings and conference calls with study teams and staff members.
8. Performs or assists with research compliance audits or self-assessments.
9. 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.

Salary Range

$55,000.00 - $85,000.00