Clinical Specialist

Ockham Raleigh , NC 27611

Posted 2 months ago

Job Overview:

We are seeking a Clinical Specialist for our GSS group to review and codify client informed consent documents into GSS GloblaCODE system. Also interprets client protocol documents to build the Specimen Test Plan in the GSS GloblaCODE system.

Will be responsible for retrieval, review, codification of client informed consent documents. QC peer completed codification. Attend client meetings as codification representative. Works with client on client specific standards. Other duties will include the following:

  • Codification of Informed Consents based on company SOP's

  • Entry of codification information into spreadsheet or online system

  • Peer review QC of codification

  • Collecting client informed consent documents from multiple systems

  • Tracking ICF documents received and codified for billing

  • Create, update, track client specific codification guidelines

  • Attend client meetings to discuss GSS codification processes and client specific codification process

  • Organize timelines for codification of client studies

  • Organize and re-prioritize ICF resources as needed

  • Train new ICF Codification employees

  • Development and entry into GlobalCODE of Specimen Test Plans (STP)

  • Quality Control of Specimen Test Plans

  • Update of STP based on client documentation

  • Assist with development and maintenance of documentation

  • Assist Quality Assurance in regulatory certifications (ISO, Data Privacy, etc), validation processes, SOP

writing

  • Any corporate activities assigned

Education/Qualifications:

Education Minimum Requirement: Bachelor's Degree


Required Experience and

Skills:
  • At least 3 years of experience working in clinical trials, laboratory, or specimen management

Experience:


Desired Experience and

Skills:
  • A Bachelor's degree, preferably in science or a related field

  • Knowledge of clinical specimen operations and/or informed consent documents

  • Knowledge of specimen management, clinical pharmacogenomics, or biomarker research

  • Proficient basic computer skills including Word, Excel, PowerPoint, email management

  • Ability to learn basic software applications

  • Proven ability to plan, prioritize, and manage in a fast-paced environment with a high degree of initiative

  • Strong drive for process optimization and data integrity

  • Excellent communication and interpersonal skills with great attention to detail

  • Experience writing, reviewing, or reading protocol or lab documentation, or informed consents for clinical trials

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