Clinical Research Associate

3 days ago

Apply Now

Receive Emails with Similar Jobs

Lexitas

WebsiteLinkedInAll Job Openings

Reliability Proven. Trust Earned.

Litigation Support Services • Deposition Services • Court Reporting • Records Retrieval • Realtime Reporting

501 - 1000

💰 Debt Financing on 2016-09

Description

• Oversees and reviews site activities for clinical trials via on-site monitoring visits and/or in-house assessments according to the trial-specific monitoring plan. • Oversees clinical site activities. • Monitors trial records to verify the protection and well-being of study subjects and that reported trial data is adequate, complete and verifiable from source document data. • Reviews site compliance with protocol, Good Clinical Practice (GCP), FDA regulatory requirements, and Standard Operating Procedures (SOPs). • Frequent travel to study sites is expected. • Performs pre-study, initiation, interim monitoring and close out visits according to applicable SOPs, GCP and FDA Guidelines. • Monitors clinical studies at a site level, including the review of case report forms (CRFs) to ensure adherence to the current protocol and consistency and scientific validity of the data as verified against source document data. • Manages all aspects of a clinical study at assigned clinical trial sites to ensure subject safety and well-being, adherence to appropriate safety regulations and data integrity. • Provides technical, scientific and operational guidance to study site personnel on the protocol. • Assists with the tracking and reporting of enrollment and works with site to identify enrollment issues, barriers and strategies. • Implements project specific processes and tools. • Responsible for maintaining or gathering site/project specific information as directed by sponsor and project management. • Coordinates the collection and approval of essential and regulatory documents and maintenance of site study documentation. • Assists other team members with site-specific issues, acting as liaison between study staff and project staff. • Must be able and willing to travel as the project requires. • Performs other tasks as directed by line management or project leadership.

Requirements

• Education: This position requires a B.S./B.A. in a health related or scientific field and a minimum of 2 years of experience in clinical research, or equivalent combination of education and experience • Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance • Experience in ophthalmology preferred • Some experience in field monitoring preferred • Ability to travel 60% to 70% of time • Highly customer service oriented. Quality of interactions demonstrates an emphasis on developing and retaining strong relationships internally and externally • Competent communication (both written and verbal), personable, able to develop a positive rapport with clinical sites. • Demonstrates analytical and problem-solving skills and appropriate judgement regarding issue identification and escalation • Strong attention to detail • Competent computer and organizational skills • Works well independently and as part of a dynamic project team