Psychometric Rater

Summary:

Administers and interprets quantitative tests for the measurement of psychological variables related to diseases and disorders (i.e. Alzheimer’s disease, Mild Cognitive Impairment, Multiple Sclerosis, Depression, Anxiety, and Parkinson’s Disease). Completes psychometric ratings aspect of clinical trial performance at site level in order to ensure that the data collection is in congruence with the philosophy and mission of the company, as well as with the specific scale administration guidelines.

Duties:

•           Administers psychometric ratings for clinical trials conducted by a supervising Principal Investigator in accordance to FDA, GCP, and protocol guidelines.

•           Assumes a lead role on studies, facilitating study specific Psychometric Rater training for new and on-going studies.

•           Maintains ongoing study-specific communication with sponsors and site staff regarding ratings-related protocol updates, clarifications and testing procedures.

•           Identifies potential problems or inconsistencies and takes action as appropriate.

•           Administers and interpret protocol specific scales to determine protocol eligibility under the supervision of the Principal Investigator.

•           Ensures subject safety by appropriately responding to any potential for harm to self or others identified through the course of interviews and evaluations performed.

•           Actively works to maintain consistency in the performance of ratings for individual subjects as well as for clinical trials.

•           Maintains timely source documentation as well as sponsor required information.

•           Completes all monitor and sponsor queries in a timely manner.

•           Provides educational in-services for third party vendors providing protocol specific care to subjects.

•           Ensures adherence to COP’s, SOP’s and GCP (ICH GCP and local regulations).

Qualifications:

•           Education and Experience:

•           Bachelor's degree or equivalent and relevant formal academic / vocational qualification

•           Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

•           Advanced computer skills, including proficiency with Microsoft Office and capable of learning new software/hardware

•           Strong oral and written communication skills, including the use of Business English

•           Ability to work independently or in a team environment

•           Strong attention to detail

•           Strong problem-solving abilities

•           Solid organizational and time management skills to multitask and oversee numerous studies with a variety of therapeutic areas and sizes simultaneously

•           Skilled in all types of audit preparations and oversight during audits, including sponsor, internal and regulatory authority audits

•           In-depth industry knowledge of quality compliance and GCP regulations

•           Excellent interpersonal, leadership and consultative skills

•           Detailed understanding of medical terminology