Infotree Global Solutions · 1 day ago
Psychometric Specialist
Wilmington, NC
Contract
Remote
Mid, Senior Level
$45/hr - $53/hr
5+ years exp
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Responsibilities
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).
Qualification
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Required
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).
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.
Company
Infotree Global Solutions
Infotree Global Solutions is a talent management company specializing in staffing and payroll solutions.
1001-5000 employees
H1B Sponsorship
Infotree Global Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (10)
2022 (13)
2021 (15)
2020 (28)
Funding
Current Stage
Late StageLeadership Team
Phyllis Jackson
Global Talent Partner
Raman Sawhney
Managing Partner
Company data provided by crunchbase
