Abbott · 8 hours ago
Senior Clinical Data Coordinator - C
Pleasanton, CA
Contract
Onsite
Senior LevelAbbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Senior Clinical Data Coordinator who will provide support for Investigator Sponsored Studies, ensuring quality documentation and processes while improving efficiency. The role includes data entry, problem analysis, and administrative support within a clinical research environment.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
The Investigator Sponsored Studies Associate I is an important contributor to our team
In this role, you will provide Investigator Sponsored Study (ISS) support including entering, reviewing, verifying, and organizing incoming/outgoing documentation using web-based software
This person identifies potential issues that could affect the quality of documentation and processes and recommends appropriate solutions
This person will also take initiative and assume responsibility to help improve the efficiency and quality of the ISS process, reach out to customers for clarification on missing data, and ensure that the quality of services meets internal and external procedural requirements
When appropriate, you will also give guidance to functional partners in determining solutions to ISS process issues and/or problems
You can expect to be cross trained on all ISS processes supported by Medical Device Medical Affairs
Processing incoming forms accurately and according to departmental processes
This includes the accurate and timely entry of forms into a database, the quality review and verification of forms already entered, the identification and correction of errors and the organization of clinical documentation (forms, correspondence and other supporting clinical documentation)
Analyzing problems, characterize issues and determine appropriate solutions
Providing administrative support for ISS as requested. This could include generating mail merges, faxing, copying, filing, mailings, etc
Resolving and/or facilitating resolution of problems including identifying causes of problems to prevent reoccurrence of problems
Qualification
Required
Supporting Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complying with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Clinical Data Coordinator experience or experience in a comparable or closely related clinical research environment, including direct familiarity with data management processes
Strong skills with MS Office applications, specifically Excel, Word, and PowerPoint are required
Advanced organizational skills, attentiveness to detail, ability to work under limited supervision, and ability to handle multiple projects simultaneously
Ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential
Must have comprehensive interpersonal skills, including the ability to listen, resolve relatively complex problems, and deal with unresolved issues, delays and unexpected events, while effectively communicating and maintaining rapport with field clinical engineers and study coordinators
Must be able to use discretion and handle sensitive/confidential information appropriately
Occasional overtime is a requirement of this position
Bachelor's degree (preferred) or an equivalent combination of education and work experience required
Experience with FDA, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) regulations as they apply to Clinical Data Management and to the clinical trial process
Ability to work in a highly matrixed and geographically diverse business environment
Preferred
Experience using Concur for payments is preferred
Benefits
Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account (for High Deductible Health Plans)
Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
Supplemental Life Insurance
Short Term Disability (coverage varies by state)
Long Term Disability
Critical Illness, Hospital coverage, Accident Insurance
MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
401(k)
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
Founded in 1888
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
2026-01-07
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