Senior Clinical Project Coordinator

Location
Frederick, Maryland
Salary
Competitive
Posted
Oct 20, 2020
Closes
Nov 19, 2020
Ref
2670
Function
Other
Industry
Science
Hours
Full Time
The Emmes Company, LLC is searching for a Clinical Project Coordinator located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for remote work or office location 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

•Provides support in tracking, compiling, and submitting project deadlines and deliverables

•Manages conference call accounts, schedule and distributes conference call information and materials (i.e., Agenda, Minutes, Supporting Documents)

•Arranges the planning, organization, and coordination all aspects of conference calls and meetings, including international sites and collaborators

•Facilitates communications between project staff and project sponsors regarding project development and project processes

•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

•Composes, consolidates, formats, edits, and distributes a wide variety of non-technical documents (e.g., numbered memos, site visit reports, project marketing materials)

•Develops and maintains database software for entering, retrieving, modifying, and manipulating data to generate various documents such as rosters, meeting materials, and reports

• Establishes and maintains project procedures and processes (e.g., SOPs, work instructions)

•Leads the managing of electronic and paper-based project files and archives

•Maintains the project website contents and user access

•Review quality, based on standards and SOPs and GCP guidelines, and contribute to department/TRU standardization efforts

•Responsible for tracking PubMed, NLM reporting, publications and manuscripts for the project; provides support in manuscript submission

Experience

•Bachelor's Degree preferred; equivalent working experience may be considered in lieu of degree

•6 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

• Experience with Drupal and formatting documents in eCTD preferred

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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