Abbott Clinical Data Coordinator II in Sylmar, California
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.
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: List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform.
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.
Performs other related duties and responsibilities, on occasion, as assigned.
Bachelor's Degree in Computer Science, Informatics, Health Sciences, related field, or equivalent with a minimum of two plus years’ experience working in a clinical research environment or, an Associate’s Degree or High School degree with four plus years’ experience working as a Clinical Data Coordinator or in a comparable or closely related clinical research environment, including direct familiarity with data management processes in a clinical research environment.
Experience with the U. S. Food & Drug Administration (FDA), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) as they apply to clinical data management and to the clinical trial process.
The demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and rules are essential.
Requires good organizational skills, attentiveness to detail, ability to work under general supervision and the ability to handle multiple projects simultaneously while meeting assigned deadlines.
Must have demonstrated 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.
Must be able to use discretion and handle sensitive/confidential information.
Highly skilled with MS Office, especially Excel, Word, Publisher and PowerPoint.
Ability to work with Clinical Data Management Systems.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to travel approximately 10%.
Must be able to maintain regular and predictable attendance; the ability to work overtime is also required.
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 email@example.com