Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Psychometric Specialist
Posted: 11/26/2024
2024-11-26
2025-01-04
Employment Type:
Contract
Job Category: Administrative
Job Number: 616351
Is job remote?: Yes
Country: United States
Job Description
Target PR Range: 45-53/hr
*Depending on experience
Summarized Purpose: Primarily responsible for PRO endpoint strategy including appropriate COA selection, development of evaluation plans and implementation of psychometric analyses.
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: 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:
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).
Knowledge, Skills and Abilities:
-Ability to write psychometric statistical analyses plans or clinical trial PRO endpoint analyses SAPs.
-Publications experience demonstrating expertise in instrument development including reliability, validity, responsiveness and meaningful within patient change.
-Evaluates COAs for appropriate usage in clinical trials including acceptability to FDA guidelines for implementation of COAs as primary or secondary endpoints in RCT, develops analysis plans and guides them through development of regulatory dossiers for COAs, briefing books, and support at FDA and other regulatory meeting.
-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 and strong problem-solving abilities
-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
*CO/NYC candidates might not be considered
*Depending on experience
Summarized Purpose: Primarily responsible for PRO endpoint strategy including appropriate COA selection, development of evaluation plans and implementation of psychometric analyses.
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: 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:
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).
Knowledge, Skills and Abilities:
-Ability to write psychometric statistical analyses plans or clinical trial PRO endpoint analyses SAPs.
-Publications experience demonstrating expertise in instrument development including reliability, validity, responsiveness and meaningful within patient change.
-Evaluates COAs for appropriate usage in clinical trials including acceptability to FDA guidelines for implementation of COAs as primary or secondary endpoints in RCT, develops analysis plans and guides them through development of regulatory dossiers for COAs, briefing books, and support at FDA and other regulatory meeting.
-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 and strong problem-solving abilities
-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
*CO/NYC candidates might not be considered
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