Clinical Scientist - eCOA

eResearch Technology Inc; United States; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Clario is seeking a Clinical Scientist - eCOA to ensure timely completion of Virgil eForms while upholding high quality and clinical validity. You will translate business requirements into software/workflow specifications and collaborate with global teams to support eCOA development.

The role emphasizes experience with standardized assessment tools, clinical trials, and GCP, with strong project management and communication skills to operate in a fast-paced environment.

Qualifications

• Graduate degree in psychology, social work, counseling, psychiatric nursing, or a related field.
• Minimum 4 years of experience administering standardized assessment tools and scales; structured interviews preferred.
• Minimum 2 years of clinical trial, research, or clinical setting experience.
• Knowledge of scale development and clinical assessment best practices.
• Basic understanding of Good Clinical Practice (GCP).
• Strong written and verbal communication, interpersonal, and organizational skills.

Responsibilities

• Provide clinical subject matter expertise in the development of eCOAs to meet client needs.
• Coordinate with internal teams to deliver requirements for electronic form layout, interface, and validation rules/edit checks.
• Support Validation and Testing teams through clinical validation to test and evaluate work by the eCOA team.
• Review data collected through eCOA platforms and other sources to improve functionality and clinical guidance.
• Present eCOA batteries used in large, international clinical trials to sponsors for approval/adoption.

Skills

Clinical validation

Project management

Communication

Cross-team collaboration

Analytical thinking

Problem solving

Documentation

Education

Graduate degree in psychology or related field

Tools

MS Word

Excel

Adobe

Job description

The Clinical Scientist - eCOA will be responsible for ensuring the timely completion of Virgil eForms while maintaining high standards of quality and clinical validity. This role will contribute to the organization’s operational effectiveness and excellence by collaborating with various operational teams to translate business requirements into specific software requirements and/or procedural workflows.

What You'll Be Doing

• Provide clinical subject matter expertise in the development of eCOAs to meet client needs.
• Communicate and coordinate with internal teams to deliver requirements for electronic form layout, interface, and validation rules/edit checks.
• Support Business Analyst and Test teams through clinical validation expertise to test, validate, and evaluate work completed by the eCOA team.
• Review and evaluate data collected through eCOA platforms, Independent Ratings, usability testing, surveys, and marketing research to improve functionality and clinical guidance.
• Liaise with sponsors and scale authors as needed.
• Present eCOA batteries used in large, international clinical trials to sponsors for approval/adoption.
• Collaborate with operational groups to identify and resolve clinical-related issues in services and software.
• Develop work instructions, process guidelines, and SOPs to ensure compliance with SOP/GCP requirements related to eCOA development.
• Participate in team meetings and maintain regular communication with remote staff.
• Perform other duties as assigned by management.

What We Look For

• Graduate degree in psychology, social work, counseling, psychiatric nursing, or a related field.
• Minimum 4 years of experience administering standardized assessment tools, psychiatric symptom rating scales, and/or neurocognitive scales; experience with structured diagnostic interviews preferred.
• Minimum 2 years of experience in a clinical trial, research, or clinical setting.
• Knowledge of scale development and clinical assessment best practices.
• Basic understanding of Good Clinical Practice (GCP).
• Strong project management, facilitation, and coordination skills, with the ability to manage multiple projects and priorities simultaneously.
• Strong analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication, interpersonal, and organizational skills.
• Ability to collaborate effectively across teams and lead through influence and negotiation.
• Ability to work effectively in a fast-paced environment and manage multiple priorities.
• Solid understanding of basic and intermediate statistics.
• Advanced skills in MS Word, Excel, and Adobe.
• Fluent in English; bilingual or multilingual skills preferred.

EEO Statement

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

Clario Privacy Policy

Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence generation solutions that combine medical imaging, eCOA, precision motion, cardiac solutions and respiratory endpoints. For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported over 30,000 clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2015.