Clinical Research Associate Job in Jacksonville, Florida US

Please note this is a 3 month contract position.
Skills: Pharma/Biotechnology, BS Degree, CRA experience

The CRA will plan and monitor human clinical trials in compliance with internal procedures, ICH Guidelines, Good Clinical Practices (GCP) and applicable Regulations and Guidelines. Coordinates protocol and case report form development and compilation. Insures appropriate clinical trial agreements are signed and materials are distributed. Monitors and secures protocol and regulation compliance at investigational sites. Reviews, retrieves, and reports the trial data as the requirements dictate or as is appropriate. Other key responsibilities includes: Maintains essential documents and other study-related documents; Plans and develops complex study protocols/technical reports, develops, tests, and reviews CRFs and other study materials: Assists in study implementation, which may include: investigator recruitment, site management, IRB liaison, Adverse Event management, Periodic Report generation, and/or supplier oversight; Performs other related duties as assigned by management, including process improvements and coaching new employees. May draft informed consents, protocols, sections of Investigator Brochures, and other study documents.

The CRA II will oversee internal and contract monitors, review clinical data, complete trend analysis, communicate study progress, risk, and best practices to study team. Coordinate and communicates with universities, contract research organizations, private practices, institutional review boards, and other functional groups engaged in the conduct of clinical studies

ESSENTIAL FUNCTIONS / RESPONSIBILITIES
1. Conduct clinical monitoring of company sponsored studies remotely and on-site as required. Travel to clinical sites or vendors up to 70% of time. (70%)

2. Support the management of clinical studies according to agreed timelines. (20%)

3. Organize and analyze data and identify trends, manage risk, and offer solutions. (15%)

4. Oversee contract research organizations, communicate with clinical sites, and partner with internal study teams (10%)

5. Performs other related duties as assigned by management. (5%)

For consideration please include Job # 9371.