Clinical Project Coordinator

The EMMES Corporation • Rockville, MD

106d

About The Position

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Founded more than 47 years ago, Emmes has become one of the primary clinical research providers to the US government and has expanded into public-private partnerships and commercial biopharma. The company has built industry-leading capabilities in various fields including cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. The Clinical Project Coordinator role is designed to support Emmes clinical operations teams by providing logistics support for conference calls, meetings, supplies, documentation, and client/sponsor reporting needs as required by the statement of work. This role may support Public Sector and/or BioPharma work.

Requirements

• Bachelor’s Degree preferred
• 4 years of relevant project or administrative support experience
• Demonstrated experience with MS Office Suite, particularly MS Word
• Familiarity/experience with software such as project scheduling, bibliography management, tele/web conferencing, website management
• Time management and decision-making skills
• Attention to detail and the ability to address several assignments simultaneously

Responsibilities

• Provides support with tracking project deadlines, and compiling/submitting project deliverables
• Schedules and distributes conference call information and materials (i.e. agenda, minutes, supporting documents)
• Prepares non-technical meeting minutes
• Coordinates aspects of conference calls and meetings, including with international sites and collaborators
• Assists with the organization of communications between project staff and project sponsors regarding project development and project processes
• Handles logistics of inventory and supply management for research sites
• Develops, composes, consolidates, compiles, edits, formats, tracks, and distributes technical reports (e.g., DSMB), non-technical reports (e.g., numbered memos, progress reports, site visit reports, project marketing materials), regulatory reports (e.g., IRB, IND, CSR, SAP), case report forms, manuals, presentations, and manuscripts, adhering to eCTD and/or 508 compliance guidelines, as required under the direction of the Clinical Project Coordinator Manager or designee
• Maintains database software for entering, retrieving, modifying, and manipulating data to generate various documents such as rosters, meeting materials, team training records, and general reports
• Participates in establishing and maintaining project procedures and processes (e.g., SOPs, work instructions)
• Manages electronic project files and archives under the direction of the Clinical Project Coordinator Manager or designee
• Maintains the project website contents and user access under the direction of the Clinical Project Coordinator Manager or designee
• Assists with reviewing quality, based on standards and SOPs and GCP guidelines, and contributes to department/TRU standardization efforts when applicable
• Tracks PubMed, NLM reporting, publications, and manuscripts for the project and provides support in manuscript submission under the direction of the CPC Manager or designee
• Other duties as assigned

Benefits

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees