Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

Summarized Purpose: 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: Essential 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.

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. Knowledge, 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 • 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

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.