Clinical Data Coordinator

Overview

Position Title:
Clinical Data Coordinator

Work Location:
Pleasanton, CA 94588

Assignment Duration: 6 months

Work Arrangement:
Onsite

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.
• 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.
• Experience using Concur for payments is preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.

• Reason role is open:
  Need for additional resources supporting four business units
• Projects supported:
  Full lifecycle of Investigator Sponsored Studies (ISS), including review, contracting, milestone payments, and closure
• Typical day includes: task assessment and prioritization, downloading submissions, distributing materials, scheduling team reviews, preparing agendas/minutes, updating Excel reports, contract template edits, milestone payment formulation and processing
• Success in first 90 days:
  Demonstrated teamwork, system understanding (I-Envision, Concur, Contract Hub, Onit, OCR), functional Excel capability, and ability to streamline processes
• Past interview challenges:
  Candidates confusing role with clinical study manager; some candidates overqualified and unwilling to perform admin tasks; misunderstanding of ISS from company perspective