Clinical Data Coordinator

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Clinical Data Analyst I. This role will be working under general supervision, is responsible for various special projects related to the data management aspects of the clinical studies. These special projects will help to ensure the integrity of the clinical data. Interfaces between the Data Management and Systems Development groups within the Clinical Data Systems department. Enforces defined standards for content of new Case Report Forms (CRF) and ensures that forms meet Good Clinical Practices (GCP) requirements. Routinely uses the most effective, cost efficient and best business practices to execute processes. Exercises basic judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Assures that quality of services meets internal and external customer requirements.
Job Duties:
+ Performs all data coordination and some elements of data management activities for assigned studies on time and with high quality, as appropriate
+ 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
+ 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.
Required Qualifications:
+ A minimum of two plus years? experience working in a clinical research environment or or in a comparable or closely related clinical research environment, including direct familiarity with data management processes in a clinical research environment.
+ Requires advanced organizational skills, attentiveness to detail, ability to work under limited supervision and the ability to handle multiple projects simultaneously while meeting assigned deadlines.
+ Must also have demonstrated verbal and written communication, interpersonal, organizational and math skills.
+ The comprehensive ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation.
+ The demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and rules are essential.
+ Highly skilled with MS Office, especially Excel, Word and Publisher and PowerPoint.
+ Strong ability to work with Clinical Data Management Systems.
+ Ability to work in a highly matrixed and geographically diverse business environment.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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