Job Description

This role is with Accellacare, part of ICON's clinical research network, where you’ll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research.

We are currently seeking a Clinical Rater to join our diverse and dynamic team. As a Clinical Rater at ICON, you will play a key role in conducting structured clinical assessments and rating scales to support the evaluation of study participants. You will work closely with investigators and cross-functional teams to ensure high-quality, reliable data that supports the integrity and success of our clinical trials.

Title: Clinical Rater

Location: 4300 Long Beach Blvd, suite 500, Long Beach, CA 90807

Onsite - Long Beach, CA

Clinical Rater:

• Participate in rater certification and re-certification required by the Sponsor or CRO
• Collaborate with PI/Sub-I to discuss clinical presentation, diagnostic formulation, and scale scoring.
• Work closely with data management teams to resolve data queries related to rating scales.
• Participate in internal training programs related to psychiatric/cognitive assessments and participant de-escalation.
• Attend required Investigator Meetings (IMs), rater training meetings, rater certification sessions, and ongoing study-update calls
• Conduct standardized psychiatric rating scales such as: HAM-D, MADRS, YMRS, HAM-A, PANSS, CDRS-R, CGI
• Perform interview/ratings on study subjects to determine current levels of functioning throughout the duration of the study.
• Follow study specific guidelines for administration of proper scales.
• Ensure subject safety by appropriately assessing and responding to any potential for harm to self or others and reporting it appropriately.
• Actively work to maintain consistency in the performance of ratings over time for individual subjects to ensure efficacy and prevent rater drift.
• Knowledgeable of Diagnostic and Statical Manual for Mental Disorders version 5, 5CR, 5TR and future amendments or revisions.
• Proficient in conducting diagnostic rating scales, such as the SCID, M.I.N.I, K-Sads.
• Perform interview/ratings on study subjects to create a clinical impression of the subject’s current psychiatric or cognitive state throughout the duration of the study.
• Articulate ratings issues to CRO and/or Sponsor, Principal or Sub-Investigator and other members of the study team
• Maintain accurate, complete, and timely visit source documentation as well as sponsor required information.
• Complete subject’s clinical intake form (i.e., psychiatric history) and submit to the study team as specified.
• Assess and complete subject eligibility (i.e. screening forms).
• Interact with medical monitor regarding subject inquiries.
• Perform continuous reviews of eligibility criteria (i.e., inclusion and exclusion criteria) for each participant during the screening / randomization period.
• Verify diagnosis/clinical eligibility for telephone screens and pre-screens with potential study candidates.
• Utilize technology required to conduct required clinical assessments.
• Become familiar with and adhere to policies and procedures of confidentiality, informed consent, and study subject rights (e.g., California Subject Bill of Rights).
• Become familiar with and adhere to principles of Good Clinical Practices and general ethical guidelines, as related to clinical trials.
• Become familiar with and adhere to the FDA Regulations pertaining to clinical trials.
• Review medical history with Clinical Research Coordinator (CRC) information obtained at screening.
• Review and reconcile medical records received for subjects; prepare Principal Investigator (PI) notes to explain discrepancies, where applicable.
• Creates tools and assessments to ensure effective training of clinical outcomes assessment raters/interviewers
• Assist team in management and assessment of adverse events.

Qualifications:

• Minimum of a MD required
• + 1 years of Rating experience
• Skill in developing and maintaining effective working relationships with study participants, families, staff and the public
• Ability to complete paperwork with precision and attention to detail
• Ability to interpret, adapt and apply guidelines and procedures
• Ability to work independently as well as functioning as part of a team

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