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Clinical Research Specialist

2+ years
Not Disclosed
10 June 12, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Responsibilities:

  • Site Management experience (site or sponsor).

  • Knowledge of/experience with CTMS/EDC/TMF.

  • Experience with Good Clinical Practice (GCP).

  • Oversees, designs, plans, and develops clinical evaluation research studies.

  • Prepares and authors protocols and patient record forms.

  • Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.

  • Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.

  • May be responsible for clinical supply operations, site and vendor selection.

Requirements:

  • Requires a University Degree and minimum of 2 years of relevant experience.