Senior Clinical Data Coordinator - C
HireTalent
Pleasanton, CA
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JOB DETAILS
LOCATION
Pleasanton, CA
POSTED
30+ days ago
Duration: 6+ Months of Contract role (Potential to convert to full-time)
Work Location: Pleasanton, CA 94588
Shift - 8 am to 5 pm
" Top 3 required skills: Strong willingness to perform duties and work as a team; proficiency in MS Office (Excel especially); strong grammar/writing with low error rate
" Top *** preferred skills: Ability to learn quickly (within ~2 months); high Excel capability (pivot tables, programming helpful); proactive approach to process improvements
" Certifications/education: Some college acceptable; bachelor s preferred
" Industry experience: Medical/pharma/biotech experience preferred; ISS experience a major plus but not required
" Systems used daily: Microsoft Office/Teams/Excel; I-Envision; Concur; ContractHub (Salesforce); Onit; OCR; Ariba
" Personality traits: Self-awareness, willingness to learn, team-oriented, receptive to feedback
The Opportunity
Our location in Pleasanton, CA currently has an opportunity for an Associate position for our Investigator Sponsored Studies team. In *** s Heart Failure (HF) business, we re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.
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.
What You ll Work On
" 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.
Required Qualifications
" 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.
Preferred Qualifications
" 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.
About the Company
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