PURPOSE
Responsible for administering clinical study assessments on a study (MCCB and Tower of London scale). Observes the study participant’s symptoms and documents observations appropriately via psychiatric rating scales in accordance with study-specific requirements. Follows individual study participants through the study lifecycle and
maintains documentation of observations for reporting purposes.
RESPONSIBILITIES
• Administer clinical rating scales s to support the diagnosis and assessment of symptom severity of
subjects participating in CNS and neuro/psych clinical studies.
• Attends, completes, and qualifies for study-specific rater training and certification for trials on which they rate.
• Measures the severity of symptoms of study participants
• Continuously observe the study participants using approved assessments throughout study
• Reports to and works under the guidance of the principal investigator and/or sub-investigator for the study site where the study participant is seen
• Assist team in management and assessment of adverse events
• Support PI/SubI and study coordinators with assessments, data clarification, and data query completion• Serve as SubI where applicable under the delegation of the PI
EDUCATION AND EXPERIENCE
• Medical degree-PhD, MD or DO, will consider PA or NP with extensive rating experience
• Minimum two years of clinical experience and research experience with neuropsychiatric population
• Minimum two years of rater experience supporting clinical trials
o >25 assessments in the last year preferable
• Competency in rating scales as required by studies. Experience in specific scales will be assessed as needed for specific projects. Raters will undergo study rater training as required for each project. Compliance with all in-study rater training obligations and certification processes through trial duration.
Required Scales with Experience Rating:
--EDSS certification through NeuroStatus platform.
--Examining Investigator/rater should have prior experience conducting the EDSS assessment and other efficacy assessments (T25FWT and 9HPT).
ADDITIONAL ATTRIBUTES
• Functional knowledge of ICH/GCP guidelines
• Functional knowledge of HIPAA and its application to clinical research
• Excellent oral and written communication skills
• Ability to function independently
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The potential base pay range for this role is The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.