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Clinical Quality Specialist at Oxford Global Resources, LLC in Trenton, New Jersey

Posted in General Business 30+ days ago.

Type: Full-Time

Job Description:


Responsible for executing on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials

Project Details:

  • Assist with the evaluation, selection and management of external vendors to ensure successful clinical trial implementation and execution

  • Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with GCP and ICH guidelines

  • Work closely with the Program Lead to coordinate, track, and manage all logistics in support of the clinical Program

  • Accountable for managing study budgets, including invoice and PO management/reconciliation, month end actuals and accruals in support of the Program Lead and Finance

  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships

  • Assist with authoring of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary

  • Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials

  • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed

  • Assist with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations

Job Experience:

  • BA/BS (preferably in industry or healthcare of science field) with 3-5 years progressive experience in clinical operations

  • Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance

  • Ability to handle a high volume of highly complex tasks within a given timeline

  • Ability to lead a cross-functional team in a matrix environment

  • Extensive experience managing clinical programs, CROs, budgets, and timelines required

  • Strong working knowledge of MS Project and developing Gantt charts

  • Excellent interpersonal and negotiation skills

  • Strong verbal and written communication and presentation skills

  • Proactively seeks out and recommends process improvements

Oxford is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email . We will make a determination on your request for reasonable accommodation on a case-by-case basis.