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Clario

Clinical Scientist - eCOA

Posted a day ago
2-5 years experience
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AI Summary

The Clinical Scientist will provide subject matter expertise in the development of eCOAs and coordinate with internal teams to define software requirements and validation rules. They will also review clinical data, ensure compliance with GCP standards, and collaborate with sponsors to facilitate the adoption of eCOA batteries in clinical trials.

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. 

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