CRA IIApply Now

Category: CRA
Location: Home-Based
Salary: TBD

Job Description:

Responsibilities

• Serve as a liaison between clinical trial sponsor(s) and sites
• Conduct site qualification, initiation, monitoring and close-out visits of moderate to complex clinical studies according to regulatory standards, SOPs and contract requirements
• Identify, evaluate and recommend principal investigators
• Monitor case report forms for completeness and accuracy through verification of subject records and source documentation
• Ensure compliance with protocol and overall clinical objectives
• Monitor investigator study files for compliance and accuracy
• Verify clinical trial material/investigational product accountability and compliance
• Serve as a resource to site personnel
• Identify and implement ways to improve site performance (e.g., increase enrollment rate or improve case report form completion)
• Independently act as Project Lead when requested to assist with study management and to serve as a liaison between Company and the sponsor
• Compile and track project metrics
• Implement and maintain TrialWorks and other designated project tracking tools
• Report the status of clinical studies to the Project Lead as required
• Analyze and evaluate clinical data
• Write, proofread and/or edit documents related to clinical research, including but not limited to clinical monitoring plans, project lead reports, monitoring visit reports, case report forms, telephone contact reports, sponsor and investigator correspondence, notes to study files, meeting agendas and meeting minutes
• Develop familiarity with all applicable regulations and with clinical literature about specific therapeutic areas and attend continuing education classes and project team meetings, as necessary to gain expertise
• Identify and recommend resource needs (at research sites and within the company)
• Train and assist others in the clinical research process and/or corporate policies and procedures
• Other duties, as assigned.


Job Requirements:

Qualifications

• Bachelors degree in Biological Sciences, Nursing or equivalent preferred
• Minimum of 2 years of scientific/clinical research associate experience (CRA certification preferred)
• Knowledge of drug and/or device industry
• Knowledge of US federal regulations, ICH Guidelines and GCP
• Committed to quality and excellence
• Excellent organizational skills
• Strong communication skills (verbal/written/presentation)
• Computer proficiency, including use of standard software (word processing, spreadsheet, graphics, databases and e-mail) and use of the internet
• Time management skills and problem solving abilities
• Ability to travel a minimum of 60%.

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