Wilmington, NC, 28407, USA
1 day ago
Psychometric Specialist
Join a Leader in Pharmaceutical Innovation as a Psychometric Specialist! Adecco is excited to partner with a globally recognized organization that sets the standard in pharmaceutical services, specializing in drug development and clinical trial logistics. This is your opportunity to play a vital role in advancing groundbreaking healthcare solutions by contributing your expertise to a dynamic, industry-leading team. **Pay-** The anticipated wage for this position is between $45 and $53. Hourly wage depends upon experience, education, geographic location and other factors. **Location - Remote - Must reside in Pacific Time Zone** **Essential Functions:** Administers and interprets quantitative tests for measuring psychological variables related to diseases and disorders (e.g., Alzheimer's disease, Mild Cognitive Impairment, Multiple Sclerosis, Depression, Anxiety, Parkinson's Disease). · Completes psychometric ratings for clinical trial performance at the site level to ensure data collection aligns with the company's philosophy and specific scale administration guidelines. · Administers psychometric ratings for clinical trials under the supervision of a Principal Investigator, following FDA, GCP, and protocol guidelines. · Assumes a lead role in studies, facilitating study-specific Psychometric Rater training for new and ongoing studies. · Maintains ongoing communication with sponsors and site staff regarding ratings-related protocol updates, clarifications, and testing procedures. · Identifies potential problems or inconsistencies and takes appropriate action. · Administers and interprets protocol-specific scales to determine protocol eligibility under the supervision of the Principal Investigator. · Ensures subject safety by responding appropriately to any potential harm identified during interviews and evaluations. · Works to maintain consistency in the performance of ratings for individual subjects and clinical trials. · Maintains timely source documentation and sponsor-required information. · Completes all monitor and sponsor queries promptly. · Provides educational in-services for third-party vendors providing protocol-specific care to subjects. · Ensures adherence to COPs, SOPs, and GCP (ICH GCP and local regulations). **Requirements** · 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). · Publications experience demonstrating expertise in instrument development, including reliability, validity, responsiveness, and meaningful within-patient change. · Ability to write psychometric statistical analyses plans or clinical trial PRO endpoint analyses SAPs. · Evaluates COAs for appropriate usage in clinical trials, including acceptability to FDA guidelines for implementation of COAs as primary or secondary endpoints in RCTs. · Develops analysis plans and guides them through the development of regulatory dossiers for COAs, briefing books, and support at FDA and other regulatory meetings. · Advanced computer skills, including proficiency with Microsoft Office and capability to learn 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. Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility **Pay Details:** $37.00 to $38.87 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: + The California Fair Chance Act + Los Angeles City Fair Chance Ordinance + Los Angeles County Fair Chance Ordinance for Employers + San Francisco Fair Chance Ordinance
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