Clinical Trials Coordinator / Data Manager

Clinical Trials Coordinator / Data Manager for the International Breast Cancer Study Group, a non-profit clinical trials research organization, to work internally with data management teams, trial coordinators, biostatisticians, and programmers, as well as external healthcare sites, medical personnel, and study teams.

Primary Areas of Responsibility:

  • Communicate with sites regarding clinical trial start-up, training, conduct and close-out activities
  • Collect and review regulatory documents from sites
  • Create, organize and maintain tracking systems and tools to support the conduct of trials from start-up to close-out
  • Distribute and triage communications to/from sites, external collaborators, and colleagues
  • Support of site personnel via email, phone or web-based trainings
  • Participate in procedure development
  • Review and validation of clinical trial data (patient history, tumor characteristics, treatment, Adverse Events, follow-up, etc.)
  • Discrepancy checking and querying
  • Development, review and understanding of data management documentation (protocols, manuals, case report forms, etc.)
  • Production of quality control reports
  • Support of site personnel via email, phone or web-based trainings.

Requirements:

  • Bachelor's Degree, preferably in a related field
  • Familiarity with medical concepts and terminology
  • Documentation experience
  • Excellent communication skills and the ability to build effective relationships with site staff and colleagues
  • Strong working knowledge of MS Office Suite and excellent overall technical skills
  • Excellent organizational and problem-solving skills
  • Detail-oriented, resourceful, positive and professional demeanor
  • Ability to work with people from diverse backgrounds, work independently, multi-task, adapt to changing priorities, perform job duties with minimal guidance, and meet deadlines
  • On the job learning.

Highly desirable but not required:

  • Prior Clinical Trials management experience
  • Foreign language skills (especially German and Italian)
  • Knowledge of DataFax database management system.

This position is located in our Amherst, NY office and cannot be done remotely.

Email resume/cover letter to jobs@fstrf.org and include TCDM20181221 in the subject line.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, or veteran status.