EVMS

  • Director of Clinical Research Operations

    Position Number
    2889602
    Department
    OB/GYN - CONRAD
    Category
    Management
    Compensation Max
    USD $165,000.00/Yr.
    Compensation Min
    USD $155,000.00/Yr.
    Location : Location
    US-VA-Arlington
  • Overview

     

     

    This person is responsible for coordinating the clinical studies funded by CONRAD and will lead the Clinical Team to achieve seamless management and execution of clinical trials.  The Director of Clinical Research will develop and implement clinical operations strategies, leading the execution of clinical trials, in collaboration with the Medical Director.  This person will oversee coordination and management of the clinical studies funded by CONRAD.  As Director of Clinical Research, this person will work closely with the other CONRAD directors on the clinical sections of CONRAD’s work plans, funding applications and regulatory submissions.  This position is located in our Northern Virginia office in Arlington, VA.

     

     

     

    Responsibilities

     

    Clinical Operations: Oversee planning, implementation, and reporting of CONRAD clinical trials

    • Set strategy for effective operational management of clinical trials
    • Ensure clinical studies meet milestones and timelines
    • Improve efficiencies within clinical operations, including oversight of SOPs and implementation of risk evaluation and mitigation processes for clinical studies
    • Ensure clinical studies are properly resourced, managed and executed within budget
    • Participate in the design, development and review of clinical trial protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents and study reports
    • Identify study sites and investigators for clinical studies with Medical Director
    • Oversee planning for investigator meetings and ensure studies are monitored to industry standards including travel to sites when necessary
    • Work with Product Development group to oversee packaging, labelling, and distribution of study drug supply from manufacturer to study sites
    • Participate as required in the preparation of the clinical contribution to IND and IDE’s, Investigational Brochure, regulatory Briefing Documents, and other relevant documentation for submission to FDA and other regulatory authorities
    • Oversee electronic and paper file management, including maintenance and archiving of Trial Master Files and other clinical trial documents in compliance with applicable guidelines and regulations
    • Accountable for conduct of clinical trials in compliance with GCP and all relevant regulations, policies, and ethical standards

    Contract Management: Responsible for overall oversight of sub-agreements and contracts in support of CONRAD clinical trials

    • Responsible for workscope development, vendor selection, negotiations, and oversight for collaborations and services such as data management/statistical analysis, laboratory analysis
    • Technical monitor on multiple and diverse funding agreements

    Funded Program Management: As member of CONRAD’s Senior Management Team, work to facilitate communication with and reporting to project funders

    • Participate in work plan development and monitoring
    • Prepare routine reports (semi-annual and/or annual) for CONRAD funders
    • Prepare presentations and participate in meetings as needed to update funders and discuss program status

     

    Proposal Development: Collaborate with CONRAD Senior Management Team to develop and submit proposals for funding

    • Provide input on study design and budget development
    • Support resource allocation

    Supervise

    • Lead team of 5 to 8 people, including Project Managers, Clinical Research Associates, and support staff
    • Provide mentorship to direct reports and maintain clear communication on performance
    • Build and maintain positive team-based culture


     

    Qualifications

    Master's degree, preferably MPH, and 10 years experience in clinical research with supervisory experience is required.  Must have demonstrated ability to manage a clinical research project through all stages. 

    Location : Location

    US-VA-Arlington

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