Protocol Specialist

Location
Rockville, Maryland
Salary
Competitive
Posted
Nov 07, 2019
Closes
Dec 07, 2019
Ref
2214
Function
Other
Industry
Science
Hours
Full Time
The Emmes Company, LLC ("Emmes") is searching for a Protocol Specialist located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia offices. Emmes has offices located at the below locations and throughout the greater Washington, DC area with flexibility for office location preference, dependent upon position.

The Emmes Company, LLC, established in 1977, is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six 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 provide 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

This position will support The National Eye Institute Support (NEIS) project. Emmes staff collaborates closely with NEI investigators in support of various activities, including statistical and scientific expertise in study design, protocol development and data analysis, study implementation, site monitoring, protocol navigation and coordination, regulatory submissions, and computer system development for data collection and quality control. Additional multi-center trials have been implemented, which expanded Emmes' support to clinics outside NEIS.

Trials conducted under this contract span various diseases, including inflammatory disorders, motility disorders, age-related dysfunction, and genetic disorders. The clinical research coordinated by NEIS undertakes a variety of study designs, such as single-center, multi-center, randomized and non-randomized clinical trials, genetic, and natural history studies. Currently activated protocols include trials that examine novel approaches in treating participants with age-related macular degeneration, diabetic macular edema, branch and central retinal vein occlusion, retinitis pigmentosa, von hippel landau disease, x-linked retinoschisis, scleritis, and uveitis.

The Protocol Specialist has the overall responsibility for and focused work effort in three major areas: 1) medical writing/editing 2) regulatory/compliance to review requirements; and 3) protocol coordination/navigation and administration. In addition, the Protocol Specialist works closely with Protocol Monitors, Regulatory Affairs Specialists, Data Managers, Project Managers and Statisticians to ensure compliance with regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), the study protocol and overall research objectives. Local travel is required.

Responsibilities

  • Coordinate/Navigate the writing and development of new protocols (and changes to existing protocols) with the Principal Investigators (PIs) and members of the study team
  • Write informed consent forms in compliance with appropriate guidelines
  • Ongoing review of existing protocols to ensure regulatory review deadlines are met
  • Edit protocols and informed consent forms when amendments are required and as requested by regulatory committees or the Sponsor
  • Facilitate communication and feedback between various study team members
  • Coordinate the appropriate regulatory review processes by the ICRRC, DSMC and IRB, as appropriate
  • Organize and run regular operational meetings between the protocol team and study investigators. This may involve preparing and/or reviewing meeting agendas and minutes
  • Communicate and coordinate effectively with internal and external clients and colleagues
  • Provide recommendations for process improvements
  • Demonstrate understanding of corporate SOPs and project guidelines by producing work in compliance with the SOPs and guidelines
  • Attend and participate in project and functional group meetings and may be responsible for preparing and distributing meeting minutes
  • Complete continued education (e.g., successful completion of CCRA or CCRP certification)


Experience

  • Bachelor's degree in a scientific discipline or equivalent experience
  • Minimum 1 year of experience clinical trials research preferred
  • Demonstrated ability to comprehend scientific literature in the field of study
  • Excellent oral and written communication skills
  • Ability to work independently, as well as in a complex team environment
  • Self-motivated and detail-oriented
  • Skills in prioritization, problem solving, organization, decision-making, time management and planning
  • Training in and demonstrated understanding of the regulatory obligations of the relevant GCP and ICH guidelines


Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.

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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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