What are the responsibilities and job description for the Clinical Research Associate position at Actalent?
Description:
Provides administrative and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice(GCP), guidelines, standards, federal regulations and SOPs. Close collaboration with other members within Clinical R&D. Effectively manages clinical study activities including design, planning, implementation, and overall direction of clinical research projects.
Core Job Responsibilities
• Effectively manage multiple clinical studies (2 studies, cataracts and laser studies) and assigned sites to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials while providing moderate level study management support. (sites located in southern CA, Northern CA, UT)
• Under the support of a Study Manager, contribute to study design, development, conduct and closure.
• Create, review and/or revise key study documents, including but not limited to protocol, investigator brochures, informed consent document templates, monitoring plans, and annotated monitoring visit report templates.
• Develop and implement a clinical trial training plan for internal and external personnel, including CRAs, CRA Assistants, and investigative site personnel.
• Provide leadership, protocol and monitoring support to CRAs allocated to assigned clinical trials, including resolution of team member conflict and communication issues, with support from Regional Managers and others, as needed.
• Responsible for study start-up activities including managing essential trial documents.
• Review and approve completed monitoring visit reports.
• Serve as primary contact for investigative site communication for each assigned site.
• Train investigative site personnel to ensure compliance with study requirements and GCP, including, but not limited to the protocol, IRB/EC instructions, industry
guidelines, international standards and local and national regulations.
• Evaluate actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets
• Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
Skills & Qualifications:
• 1-3 years of clinical research experience with significant independent field monitoring experience is required.
• Ophthalmology experience is required
• Medical Device industry experience is preferred.
• Knowledge of ophthalmology is required.
• Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials, is required.
• Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities is preferred.
• Ability to problem-solve is required.
• Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external
meetings is preferred.
• Proficiency with MS Word, Excel and PowerPoint is required.
• Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate is required.
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $55 - $65
