Lead Clinical Project Coordinator

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Lead Clinical Project Coordinator

US Remote Worker

The Emmes Company, LLC ("Emmes) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

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 prederred; 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


Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Unlimited Approved Leave
  • Tuition Reimbursement
  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US
  • Maternal/Paternal Leave
  • Casual Dress Code & Work Environment


CONNECT WITH US!

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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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