Clinical Rater

ICON plc•Long Beach, CA

1d•Onsite

About The Position

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.

Requirements

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

Responsibilities

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.