Clinical Data Coordinator in Los Angeles, CA at Apex Life Sciences

Date Posted: 5/25/2018

Job Snapshot

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    Not Specified
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Job Description


  • Working under general supervision is accountable for completing assigned duties accurately, on time and according to department procedures.
  • Is responsible for ensuring the integrity of clinical data both in the clinical database and in the clinical patient files.
  • Proactively identifies potential issues that could affect the quality of clinical data and partners with the Clinical Data Analyst (CDA) to resolve them as appropriate.
  • Follows Good Clinical Practices (GCP) and Good Clinical Data Management Practices (GCDMP).
  • Enters, reviews, verifies, modifies and organizes incoming clinical documents and data.
  • Takes initiative to improve the efficiency and quality of data management processes.
  • Often exchanges information with, or provides a service to, all levels of employees within the global Clinical Affairs organization as well as Clinical Centers.
  • Does not require instructions for routine assignments; requires some general instructions for new or special assignments.
  • Ensures that quality of services meets internal and external customer requirements.
  • Adapts work methods to different situations.

Job Duties:

  • Performs all data coordination and some elements of data management activities for assigned studies on time and with high quality, as appropriate o
  • Reads and understands clinical study protocols
  • Reviews and provides comments on draft CRFs
  • Reviews, provides input into and follows the Data Management Plan
  • Creates CRF Completion Guidelines
  • Tests study database o Assigns Sites, Field Clinical Engineers and Patients to Sites
  • Creates Data Entry Guidelines
  • Ensures Self-Evident Correction process and data handling standards are appropriately applied
  • Creates paper patient files; prepares paper patient files for scanning and archiving
  • Enters study data into Clinical Database
  • Supports discrepancy management process
  •  Handles receipt of clinical documents received though the general fax and email accounts and triages and distributes other received clinical documents (clinical data forms, regulatory documents, correspondence and other supporting clinical documentation) to appropriate internal personnel
  •  Addresses assigned Clinical Data Operations Help Desk/Support requests
  •  Reconciles monitored CRF with entered CRFs
  • Perform data quality audits
  • Participates in Post Market Surveillance reporting as appropriate
  • Accurately maintains administrative data in the clinical trial database: sites, physician and internal data
  • Analyzes problems and determines appropriate clinical data coordination solutions.
  • Resolves and/or facilitates resolution of problems.
  • Communicates clearly and effectively with peers, study teams and management as appropriate to support studies and goals.
  • Maintains positive and cooperative communications and collaboration with all levels of employees and Clinical Site personnel.
  • Contributes to continuous improvements in Clinical Data Coordination processes and templates, as needed/assigned
  • May represents all Clinical Data Coordinators on cross-functional task forces *
  • Applies and promotes best practices and established standards
  • Is a Subject Matter Expert (SME) in one or more areas within Clinical Data Coordination activities
  • Complies with U.S. Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH), ISO 14155, other regulatory requirements, Company policies, operating procedures and processes. 
  • Performs other related duties and responsibilities, on occasion, as assigned.