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