Psychometric Rater

Job Duties

• Administer psychometric ratings for clinical trials in accordance with FDA, GCP, and protocol guidelines.
• Assume a lead role in studies, facilitating study-specific psychometric rater training for new and ongoing studies.
• Maintain ongoing study-specific communication with sponsors and site staff regarding ratings-related protocol updates, clarifications, and testing procedures.
• Identify potential problems or inconsistencies and take appropriate action.
• Administer and interpret protocol-specific scales to determine protocol eligibility under the supervision of the Principal Investigator.
• Ensure subject safety by appropriately responding to any potential for harm to self or others identified during interviews and evaluations.
• Actively work to maintain consistency in the performance of ratings for individual subjects and clinical trials.
• Maintain timely source documentation as well as sponsor-required information.
• Complete all monitor and sponsor queries in a timely manner.
• Provide educational in-services for third-party vendors providing protocol-specific care to subjects.
• Ensure adherence to COP’s, SOP’s, and GCP (ICH GCP and local regulations).

Essential Skills

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Previous experience comparable to 5 years.
• Advanced computer skills, including proficiency with Microsoft Office and the ability 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.
• Strong problem-solving abilities.
• Solid organizational and time management skills to multitask and oversee numerous studies with various therapeutic areas and sizes simultaneously.
• 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.
• Excellent interpersonal, leadership, and consultative skills.
• Detailed understanding of medical terminology.
• 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 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.

Pay and Benefits

The pay range for this position is $45.00 - $53.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 24, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $45 - $53