Protocol Specialist (Oncology)

Location
Rockville, Maryland
Posted
Feb 21, 2019
Closes
Mar 01, 2019
Function
Other
Industry
Healthcare
Hours
Full Time

The Emmes Corporation, established in 1977, is a woman-owned, private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, 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 offer statistical support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Emmes is seeking a Protocol Specialist

Project

This position will support the Blood and Marrow Transplant Clinical Trials Network, established in October 2001 to conduct large multi-center clinical trials. The purpose of the trials is to address important issues in hematopoietic stem cell transplantation to further the understanding of the best possible treatment approaches. The BMT CTN is comprised of 37 clinical centers in the United States and a Data Coordinating Center (DCC). Emmes serves as the DCC, along with two other organizations.

Responsibilities

  • Utilize project management tools and practices to coordinate the development of new protocols including developing necessary documentation (Operations Manuals, Standard Operating Procedures, and other required documentation) with the protocol development team, managing timelines (concept development, initiation, implementation and closeout) and other tasks as needed
  • Meet deadlines for deliverables to sponsor and assist the rest of the DCC team in doing so as appropriate
  • Critically review and comment on study protocols, informed consents and other study documents as needed
  • Address study wide issues
  • Collect and review regulatory documents and advise the protocol teams on sponsor regulatory requirements
  • Collaborate with internal and external team members to improve study conduct, monitoring and assure compliance with study procedures
  • Responsible for approximately two or three different protocols
  • Participate on conference calls with Protocol Teams during development and implementation stages offering assistance and guidance as appropriate
  • Seek and develop internal and external resources to assist you in accomplishing goals
  • Develop rapport and strong, productive relationships with protocol operations team
  • Willing and eager to seek out creative and innovative resolutions to issues or problems and think strategically
Experience

    Bachelor’s degree in a scientific discipline or equivalent experience 1-2 years of monitoring or study coordinator experience preferred Skills in prioritization, problem solving, organization, decision-making, time management and planning Prior knowledge of GCP, HSP and regulatory guidelines and regulations helpful Detail oriented, excellent presentation, oral and written communication skills required Ability to function effectively on a team, providing and receiving constructive feedback Experience in clinical research, specifically oncology, hematopoietic stem cell transplantation and cellular therapy is a plus

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

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The Emmes Corporation 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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