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Miles
Km80.5

Bilingual Clinical Research Coordinator

Sonendo, Inc.

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Location: Laguna Hills, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: 130128 CRC Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Research

Description

Responsibilities:

Study Coordination
• Conduct clinical trials using good clinical practice (GCP)
• Coordinate and manage the collection of regulatory documents
• Coordinate and work closely with subjects, investigators, sponsors, CROs, and referring dentists
• Manage, request, and maintain records of clinical research budgets and payments
• Manage and document the use of investigational devices
• Serve as a liaison between investigators and representatives from sponsor and CROs
• Attend and participate in appropriate study meetings with sponsor and CRO
• Implement and review tracking systems for assigned projects to assure that timelines are being met as anticipated
• Conduct study device inventory, forecasting  and ordering clinical supplies
• Organize and store medical records, worksheets, Case Report Forms (CRFs) electronic and paper, Data Clarification Forms (DCFs), and other study data forms both electronically and in hard copy format

Subject Interaction
• Recruit, screen and enroll participants
• Recruit subjects while following strict human subjects procedures for protecting confidentiality
• Obtain participant informed consent
• Schedule tests and procedures
• Attend all study dental procedures and tooth extractions

Data Management
• Monitor the integrity of clinical data, conduct and adherence to regulatory and sponsor guidelines
• Collect data systematically, complete case report forms per protocol, maintain source documents and study files in an organized manner
• Ensuring accuracy of documentation
• Attend and coordinate site initiation, interim and closeout visits with Monitors and sponsor representatives.
• Enter and track research data in computer databases and study worksheets, records, and reports
• Review subject records for accuracy and completeness for each clinical visit, and identify and resolve any discrepancies/inconsistencies

Requirements

The candidate is expected to meet the following criteria:
• Fluent in English and Spanish is required
• Ability to travel to multiple clinical sites (Travel 25-75%)
• Must be responsible for their own transportation between clinical sites
• Bachelor of Science in health-related field and/or equivalent qualification and experience
• 2+ years of clinical study coordination
• ACRP or SOCRA certified CRC preferred
• Understand GCP ICH E6 and HIPAA  requirements
• Must be able to work both independently and in a team setting
• Must have excellent communication, organization and prioritization skills
• Use independent action and judgment while performing duties
• Ability to prioritize multiple tasks and achieve project timelines
• Strong computer skills including, but not limited to, the knowledge of EDC, IWRS, MS-Office products such as Excel, Word, Powerpoint
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