Senior Clinical Data Coordinator

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Smriti Kumari at email address can be reached on # .

We have Contract role Senior Clinical Data Coordinator for our client at Pleasanton, CA. Please let me know if you or any of your friends would be interested in this position.

Position Details: Senior Clinical Data Coordinator - Pleasanton, CA Location : Pleasanton, CA- 94588 Project Duration : 6+ Months Contract Pay Rate : $41/hour on W2

Description:
Candidate Profile
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 3 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: MS Office/Teams/Excel; I-Envision; Concur; Contract Hub (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 Abbott 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 (Google Cloud Platform) 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.

Screening Question:

• Can you describe your experience working in a clinical research or clinical data coordination environment?
• Tell us about your experience using Excel in a professional setting.
• How familiar are you with FDA regulations, Google Cloud Platform, or GMP requirements, and how have you applied them in your work?
• This role requires learning new systems and processes quickly while working closely with cross-functional partners.

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Smriti Kumari at email address can be reached on # .