Clinical Project Coordinator

Overview

Clinical Project Coordinator

US Remote

Emmes Group : Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The purpose of this role is to support Emmes clinical operations teams, 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.

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

Qualifications

Demonstrated experience with MS Office Suite, particularly MS Word

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 :

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote