Position summary

Support quality oversight of clinical trial assessments and rater performance across multi-site research studies by reviewing clinical interviews, evaluating protocol adherence and rating accuracy, and providing structured feedback to research personnel.

Key responsibilities

• Review recorded clinical research interviews and assessment administrations for quality, protocol adherence, and scoring accuracy.
• Evaluate interviewer competency, administration technique, probing skills, and study-specific guideline adherence.
• Assess clinician-rated outcome measures for consistency and reliability; identify scoring discrepancies, missed probing opportunities, and protocol deviations.
• Provide written feedback and remediation recommendations to the Clinical Lead for further review.
• Complete high-volume review requests with turnaround times of up to three business days.
• Complete evaluation forms, quality review reports, and sponsor- and regulatory-required documentation.
• Support site-rater quality monitoring, calibration meetings, reviewer training, and inter-rater reliability.
• Collaborate with clinical operations, project management, and training teams on quality concerns and corrective actions.
• Maintain strict confidentiality of participant and study information.

Required qualifications

• Master’s degree or higher in Psychology, Counseling, Social Work, Nursing, Psychiatry, or a related behavioral health field.
• At least three years of experience in clinical research reviews, psychometric evaluations, or outcomes assessment review.
• Experience administering, reviewing, or evaluating clinician-rated scales and structured psychiatric interviews.
• Strong understanding of Good Clinical Practice (GCP), protocol compliance, and research documentation standards.
• Experience as a centralized reviewer, central rater, quality assurance reviewer, or independent reviewer.
• Strong experience with MADRS, HAM-D / GRID-HAMD, MINI, AISRS, and ACDS.
• Experience supporting psychiatric, CNS, depression, ADHD, or other behavioral health clinical trials.
• Experience with rater remediation, rater/reviewer training, and reviewer notes and submissions.
• Excellent written communication, analytical, and technology skills; ability to work independently and manage multiple assignments.

Work environment

• Remote position with a flexible schedule based on study needs.
• Contract or part-time/full-time opportunities may be available.
• Participation in virtual training, calibration, and reviewer meetings.

To apply

Submit a resume or CV highlighting clinical research experience, assessment experience, and any reviewer, central rater, or quality assurance experience.

Key responsibilities

• Oversee the customer and partner audit program, including enhancements, scheduling, preparation, hosting, follow-up, departmental coaching, and audit responses to external auditors.
• Implement, maintain, and contribute to QA-managed programs: Corrective and Preventive Action (CAPA), Quality System Deviations, supplier evaluations and audits, Quality System Document Management, and internal Quality System audits.
• Assist QA senior management with customer and partner regulatory inspections, internal audits, and regulatory inspections of EMA Wellness.
• Assist with core product validation activities and the development, management, and maintenance of strategic measurement systems for quality and product.
• Support and track quality and regulatory requests from Sales, Operations, and other departments, including RFP/RFI responses and contract reviews, with oversight of support provided by direct reports.
• Support QA management with departmental business operations, including metrics and status updates.

Qualifications

• 5–10 years of experience in a pharmaceutical environment or other regulated industry.
• Experience in eCOA preferred.
• BS or MS in a related science.
• Excellent interpersonal, communication, written, and oral presentation skills.
• Proven experience addressing technical issues and interfacing with senior-level management.
• Demonstrated ability to influence others outside the span of control, with a strong orientation toward customer and service quality.

Key responsibilities

• Interface with client representatives and EMA Wellness project teams throughout study delivery.
• Support trial management from start-up through close-out, including documentation, audit readiness, and archiving.
• Conduct site and user training, including application demonstrations, account/subject registration, device setup, and portal access.
• Coordinate project communications, meetings, reporting, site/CRA support, translations, and study documentation.
• Support functional teams and mentor Clinical Project Associates as requested.

Qualifications

• Degree in a related field of study.
• Two years of relevant industry experience or equivalent.
• Working knowledge of GCP, ICH, FDA, and applicable healthcare regulations preferred.
• Strong written/verbal communication and proficiency with Microsoft Office.

Key responsibilities

• Coordinate study documents and eCOA data-collection workflows and monitor key study metrics.
• Support eCOA implementation, system testing, user training, deployment, and issue troubleshooting.
• Schedule and monitor central-rater appointments and support data quality and compliance activities.
• Prepare meeting materials and status reports and help monitor study timelines, deliverables, risks, and action items.
• Serve as a liaison among sites, central raters, clients, and internal teams.

Qualifications

• Bachelor’s degree or equivalent in life sciences or a related field.
• Relevant clinical research experience with exposure to eCOA platforms or electronic data collection.
• Knowledge of GCP, ICH guidelines, and applicable U.S. regulatory requirements.
• Strong organization, communication, technology, and problem-solving skills.