Psychometric Specialist FSP at Thermo Fisher Scientific

Posted in Other about 3 hours ago.

Location: Raleigh, North Carolina





Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description




Psychometric Specialist



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.


Essential Functions and Other Job Information:


Functions


• 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).


Job Complexity Works on problems of diverse scope where analysis of data requires evaluation of


identifiable factors.


Job Knowledge A seasoned, experienced professional with a full understanding of area of


specialization; resolves a wide range of issues in creative ways. This job is the fully


qualified, career-oriented, journey-level position.


Supervision


Received


Normally receives little instruction on day-to-day work, general instructions on new


assignments. Demonstrates good judgment in selecting methods and techniques for


obtaining solutions.


Business Represents the department as a prime contact on projects. Interacts with internal


Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company ("PPD"),


collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD.


Relationships and external personnel on significant matters often requiring coordination between


functional areas. Networks with senior internal and external personnel in own area


of expertise.


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).


In some cases an equivalency, consisting of a combination of appropriate education, training


and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.


Skills and Abilities:


• 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


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