Lead Clinical Project Coordinator

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The Emmes Company, LLC is searching for a Lead Clinical Project Coordinator based out of our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for the office location or work remote preference dependent upon position.

The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The purpose of this role is to support Emmes clinical operations teams, providing logistics support for conference calls, supplies, documentation, and client/sponsor reporting needs as required by the statement of work.

Responsibilities
  • Oversee CPC task assignments and ensure prompt completion of tasks
  • Meet monthly with DSC Leadership to discuss staffing and study issues or concerns
  • Manage deliverables tracking and ensure timely reporting to study sponsor, including:
    • Drafting reports and assigning team members to edit appropriate sections
    • Reviewing and finalizing content
    • Formatting and distributing reports to sponsor on or before the deliverables due date
    • Updating tracker with new contract and/or task order deliverables
  • PRB/DSMB Management
    • Manage scheduling of reviews, including future planning with the NIDA CCTN staff
    • Acquire and maintain PRB/DSMB member documentation including sensitive information (e.g., SSN)
    • Communicate with PRB/DSMB members, study investigators, NIDA CCTN staff
    • Format and finalize reports and distribute to appropriate parties
    • Moderate Zoom meetings and facilitate in person meetings (most meetings are conducted via Zoom)
    • Process honoraria and expense reimbursements
  • Develops, consolidates, compiles, edits, formats, tracks and distributes technical reports (e.g., DSMB) or regulatory reports (e.g., IND, CSR, SAP), case report forms, manuals, presentations, manuscripts, adhering to eCTD and/or 508 compliance guidelines, as required
  • Tracks PubMed, NLM reporting, publications and manuscripts for the project and provides support in manuscript submission
  • Reviews quality, based on standards and SOPs and GCP guidelines, and contribute to department/TRU standardization efforts
  • Leads the managing of electronic and paper-based project files and archives
  • Be familiar with Help Desk and Website activities assigned to other CPC staff
  • Suggest and implement process improvements where needed
  • Exercise judgement and discretion in sensitive matters whether for the PRB/DSMB or for the DSC leadership

Experience
  • Bachelor's degree preferred; equivalent combination of education and relevant work experience may be considered in lieu of a degree
  • 10 years of relevant project or administrative support experience
  • Strong familiarity and working knowledge of Microsoft Office applications, particularly MS Word
  • Strong analytical skills
  • Must be able to organize and manage workload efficiently and prioritize projects with minimal supervision
  • Must be able to work with minimal supervision to perform work that is varied and may be somewhat difficult in character
  • Provides orientation mentorship for new personnel regarding the role of the CPC in general (for non-CPC staff) and the details of the role (for CPC staff), otherwise known as orientation supervisor


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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