eCOA Clinical Scientist

The Clinical Scientist-eCOA supports development of electronic clinical outcome assessments (eCOA’s) from a clinical perspective across therapeutic areas in conjunction with IT Development, Operations Management, and Clinical Science. The Clinical Scientist-eCOA will be responsible for ensuring timely completion of electronic scales while adhering to quality standards and clinical validity. This individual will have experience conducting assessments as well as interacting with investigative sites and study sponsors. The incumbent will assist in ensuring the organization’s operational efficacy and excellence by working with the different operational units in translating groups’ business requirements to particular software requirements and/or procedural workflows.

EDUCATION REQUIREMENTS:

• Graduate degree in psychology, social work, counseling, psychiatric nursing or related field.

QUALIFICATIONS/EXPERIENCE:

• Minimum 4 years’ experience administering standardized assessment tools, psychiatric symptom rating scales and/or Neurocognition scales, experience with structured diagnostic interviews preferred.
• Minimum 2 years’ experience in a clinical trial or research setting or other clinical setting is highly preferred.
• Knowledge of scale development and clinical assessment best practices.

• Fluent in English, bi-lingual or multi-lingual skills are preferred.
• Basic understanding of GCP.

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or ability required.

• Provide clinical subject matter expertise in the development of eCOA’s to meet the client’s business needs.
• Communicate and coordinate effectively with internal teams to deliver requirements for electronic form layout, interface and validation rules/edit checks.
• Provide support to the Business Analyst and Test teams through Clinical validation expertise to test, validate and evaluate work completed by the eCS team.
• Participate in team meetings and communicate regularly with remote staff and other employees.
• Review and evaluate data collected through eCOA platforms, Independent Ratings, Independent Review, internal usability testing, surveys, and marketing research to improve functionality and clinical guidance included in eCOA’s.
• Liaise with sponsors and scale authors, as needed.
• External facing clinical representative responsible for presenting eCOA batteries utilized in large, international clinical trials, to sponsors for approval/adoption.
• Work with the operational groups who test, validate and evaluate new applications and functions, and determine clinical related issues in services and software.
• Identify the need for and develop as needed work instructions, process guidelines and standard operating procedures and ensure processes and procedures meet SOP/GCP requirements related to eCOA development.
• Perform other job duties as assigned by management.
• Ability to multi-process, delegate project tasks.
• Advanced skills in MS Word, Excel, and Adobe.

TRAVEL REQUIREMENTS:

• Ability to travel domestic and internationally, approximately 10% of the time, including overnight stays as necessary, consistent with business needs and office location.