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Clinical Project Assistant / Clinical Research Associate - Hybrid

1-5 years
Not Disclosed
12 May 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Clinical Project Assistant / Clinical Research Associate

Type:

W2 Contract & Hybrid Role

Location:

Santa Monica, CA

Job Description:

Our leading pharmaceutical client is seeking a Clinical Project Assistant/Clinical Research Associate. This role involves providing administrative assistance in site selection, study implementation, and ongoing coordination of study sites, either directly or via Contract Research Organizations (CROs).

Responsibilities:

  • Provide administrative assistance in site selection, study implementation, and ongoing coordination of study sites.
  • Monitor routine study sites, perform routine data collection, source data verification, and review regulatory documents/files in compliance with protocols, regulatory requirements, SOPs, and Monitoring Plan, as required.
  • Assist under supervision in the review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts, and clinical study reports.

Required Education & Experience:

  • Familiarity with Microsoft Word, PowerPoint, and Excel.
  • Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
  • Ability to contribute to SOP development.
  • Excellent verbal, written, interpersonal, and presentation skills.

Additional Requirements:

  • Work authorization for the United States.
  • 1+ years of work experience with Microsoft PowerPoint.
  • 1+ years of work experience with Microsoft Excel.

Application:

If you are a suitable candidate, please apply quickly!

Note: This position does not support C2C or H1B candidates.