Cognitive Rater

The Cognitive Rater is responsible for administering, scoring, and interpreting standardized cognitive and psychometric assessments for participants enrolled in clinical research studies. This role ensures assessments are conducted accurately and consistently in accordance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.

This is an excellent opportunity for a clinical research professional with a background in psychology, psychometry, or cognitive assessment who enjoys working in a fast-paced, highly regulated environment and is passionate about advancing innovative treatments that improve patient outcomes.

The Cognitive Rater will work closely with investigators, clinical research coordinators, and site leadership to support the successful execution of clinical trials while maintaining the highest standards of data quality and participant care.

Key Responsibilities

Study Coordination & Execution

• Administer standardized cognitive and psychometric assessments for clinical trials in accordance with study protocols, GCP, and applicable regulatory guidelines.
• Ensure consistency and accuracy in assessment administration and scoring across participants and studies.
• Conduct and support participant visits, including follow-up and retention activities.
• Maintain study supplies, assessment materials, equipment, and inventory.
• Maintain a thorough understanding of assigned protocols, investigational products, and study-specific requirements.
• Assist with participant screening, informed consent, enrollment, and recruitment activities as needed.
• Support community outreach and participant recruitment initiatives in accordance with study and regulatory requirements.

Clinical & Data Responsibilities

• Perform clinical procedures as trained and delegated.
• Accurately document study activities in source documents, electronic case report forms (eCRFs), and applicable study systems, following ALCOA+ data integrity principles.
• Review study data for completeness and accuracy and resolve data queries in a timely manner.
• Document and report adverse events (AEs), serious adverse events (SAEs), and protocol deviations in accordance with study protocols and regulatory requirements.

Regulatory & Quality Compliance

• Maintain complete, accurate, and inspection-ready study documentation.
• Support quality assurance and data management activities in preparation for monitoring visits, audits, and regulatory inspections.
• Complete required training, certifications, and study documentation within established timelines.
• Promptly identify and escalate protocol deviations, compliance concerns, and potential quality issues.
• Adhere to applicable FDA regulations, ICH-GCP guidelines, IRB requirements, and organizational SOPs.

Collaboration & Communication

• Maintain professional and timely communication with investigators, sponsors, CROs, clinical monitors, and internal team members.
• Collaborate with clinical research staff to ensure smooth study execution and a positive participant experience.
• Support investigator meetings, site initiation visits, and study-related training sessions.
• Assist with participant recruitment initiatives and community outreach efforts as needed.

Qualifications & Experience

• Master's degree in Psychology, Life Sciences, Nursing, or a related discipline, or equivalent relevant experience.
• Previous clinical research experience preferred, typically 1–3+ years.
• Experience administering standardized cognitive assessments, such as CDR and ADAS-Cog.
• At least one year of experience in psychometry, cognitive testing, or a related field.
• Working knowledge of GCP, FDA regulations, and ICH guidelines.
• Strong organizational, analytical, and time-management skills.
• Excellent written and verbal communication and interpersonal abilities.
• Ability to work independently while contributing effectively within a collaborative team environment.
• Proficiency with electronic data capture (EDC) systems and Microsoft Office.