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Clinical Data Coordinator

Cambridge, Massachusetts 02142

Post Date: 05/17/2018 Job ID: 1895 Job Category: Clinical: Data Management

The Clinical Data Coordinator will be responsible for supporting all data management aspects of clinical trials and will work closely with senior DM personnel, and as assigned, with CROs and other third-party providers of data services.  Activities performed are with the primary goal of ensuring data integrity and ensuring analysis ready data. 

This person will perform a variety of clinical data management supportive activities and procedures for collecting, recording, reporting and maintaining data in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning and task completions.

Job Responsibilities:
  • Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data
  • Contribute toward the administrative management of study data according to study protocol, study plans and SOPs
  • Assist with study data quality checking, query management and resolution for content, accuracy and completeness
  • Participate in completing and verifying specifications and or outputs (ex. listings, reports, metrics, data visualizations, etc.) and performing general quality control verifications for quality issues
  • Understand/follow important study documents such as Data Management Plans (DMP), validation specifications, reconciliation plans, etc.
  • Participate in UAT for build/work of EDC databases, reporting tools and other electronic systems and applications
  • Perform review, maintenance and archiving activities of DM related study documents ex. data transfer plans, electronic case report forms (eCRFs), completion guidelines, etc.
  • Perform reconciliation activities of data from external vendors
  • Managing and creating reports and or metrics to track and report data/query status
  • Contribute toward improved data management standard working practices and process improvement initiatives
  • Attend relevant study meetings and serve as support to the DM personnel and study team
  • Learn multiple EDC platforms, data visualization tools, and related processes, i.e. Rave, Comprehend, Spotfire, etc.

  • BS/MS and 1+ years of relevant work experience in clinical trials or data management in the clinical research sites or pharmaceutical/biotechnology industry
  • Independently motivated, detail oriented and good problem-solving abilities with huge drive to learn and enhance your skills
  • Proficient and willing learner of multiple systems and applications such as EDC platforms, data visualization tools and related processes. 
  • Past experiences and background in relevant industry technologies preferred. Knowledge of database design and database concepts helpful
  • Skilled computer skills including MS office products
  • Knowledge of related regulations, GCP and Good Clinical Data Management Practices
  • Skillful with medical terminology and or labs. Background in oncology & hematology

Anna Korelis

Anna is a creative problem solver who prides herself on her strong work ethic and expert communication skills. Goal-oriented and service-driven, Anna has a keen eye for the skills that enable her candidates to stand out, and digs deep to understand what motivates them to find their next opportunity.

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