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Associate Research Operations, Nonclinical Report Qc

6+ years
$28-30.20/hr
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Associate Research Operations, Nonclinical Report QC
Location: Thousand Oaks, CA 91320
Employment Type: Contract
Job Category: Scientific
Job Number: 617177
Is Job Remote?: No
Compensation: $28-$30.20/hr (Depending on experience)


Job Overview

Planet Pharma is seeking an Associate Research Operations professional to support the quality control (QC) of nonclinical reports for the Translational Safety & Bioanalytical Sciences (TS&BA) and Pharmacokinetic and Drug Metabolism (PKDM) groups. The primary focus will be ensuring data integrity and compliance with operational procedures, specifically for reports and data verification. Prior experience in a nonclinical drug safety or pharmacokinetic lab environment is preferred.

Key Responsibilities

  • Confirm the accuracy of experimental data in written reports against final summary analysis files and electronic lab notebooks (ELN).
  • Verify that data in reports accurately reflects ELN data sources and ensures traceability.
  • Coordinate and support the QC process using internal databases (e.g., ELN, CDOCs, LIMS).
  • Ensure the presence of supporting data files in approved storage locations.
  • Confirm that report formatting and proofreading meet regulatory filing requirements.
  • Own the QC review for toxicology and pharmacokinetic nonclinical study reports (non-GLP) supporting IND filings.
  • Aid in report formatting, ensuring compliance with regulatory filing requirements.

Qualifications

  • Basic:
    • Master’s degree and/or 1+ years of related laboratory support experience; OR
    • Bachelor’s degree and/or 2+ years of related laboratory support experience; OR
    • Associate degree and/or 4+ years of related laboratory support experience; OR
    • High school diploma or GED and 6 years of related laboratory support experience.
  • Preferred:
    • Strong problem-solving skills and the ability to work independently in a fast-paced environment.
    • Effective verbal and written communication skills.
    • Attention to detail and familiarity with MS Office tools (Word, Excel, PowerPoint, Outlook, Visio).
    • Knowledge of regulatory (GLP and GCP) and pharmaceutical processes.

Additional Information

Planet Pharma is an equal opportunity employer committed to diversity, equity, and inclusion. Candidates from all backgrounds are encouraged to apply.