PURPOSE
Responsible for administering clinical study assessments on a study. 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 to support the diagnosis and assessment of symptom severity of subjects participating in CNS 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 the 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/Sub-I and study coordinators with assessments, data clarification, and data query completion. Serve as Sub-I where applicable under the delegation of the PI.
EDUCATION AND EXPERIENCE
Medical Degree-Board certified psychiatrist PhD, MD or DO Minimum two years of clinical experience and research experience with neuropsychiatric population. Minimum two years of neuro psychiatric rater experience preferably, supporting clinical trials (preferably > 25 assessments in the last year). 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.
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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RESPONSIBILITIES
Administer clinical rating scales to support the diagnosis and assessment of symptom severity of subjects participating in CNS 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 the 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/Sub-I and study coordinators with assessments, data clarification, and data query completion. Serve as Sub-I where applicable under the delegation of the PI.
EDUCATION AND EXPERIENCE
Medical Degree-Board certified psychiatrist PhD, MD or DO Minimum two years of clinical experience and research experience with neuropsychiatric population. Minimum two years of neuro psychiatric rater experience preferably, supporting clinical trials (preferably > 25 assessments in the last year). 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.
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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