Kelly Services' Outsourcing & Consulting Group is seeking an In-house CRA II in Jacksonville, FL. This is a long-term, open-ended assignment and offers benefits! The In-House CRA will provide clinical research support and assistance in overseeing the conduct of clinical trials. The In-house CRA is responsible for the management of designated clinical trials including investigator recruitment and selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure successful outcome, investigator and study staff training.
• Responsible for clinical study activities for multiple clinical sites for several to many ongoing clinical studies.
• Conduct clinical monitoring site visits (primarily local) and monitor clinical trials in compliance with Vistakon Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines, appropriate communications between site and sponsor, and deliverables as assigned by sponsor.
• May assist in coordinating protocol, informed consent, and case report form development and compilation.
• May assist with study material distribution.
• Conduct clinical monitoring of study sites, ensuring test article accountability, human subject protection, and protocol adherence at investigational sites.
• Review, retrieve, and report the trial data as the requirements dictate or as appropriate.
• Ensure all work related activities and decisions embody the Johnson & Johnson Credo Values.
• Verify safety and wellbeing of study subjects are maintained for assigned study sites.
• Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
• Execute clinical trials activities following established standard operating procedures, good clinical practices, and regulatory requirements.
• Assume accountability for study site performance, providing high quality data according to overall project timeline.
• Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues.
• Respond to problems and assists in implementing corrective and preventive actions.
• Verify Investigator Site Files at assigned Study Sites are maintained according to regulations and/or Vistakon requirements/procedures.
• Support patient recruitment and retention activities. Performs Site visits and ensures study site is compliant with Study Protocol and all Federal, State, local and company regulations, policies and procedures.
• Assist with internal communication of important clinical data and events.
• Support, when required, organization of investigator and other study training meetings.
• Function as a reliable, trusted resource of accurate, up-to-date study site status knowledge as requested by key stakeholders.
• Understand business value of clinical projects and balances overall business objectives and functional needs.
• May be involved in other tasks to support Clinical Operations and Operating Company as needed.
• Support the implementation of new clinical systems/processes.
• Interface and collaborate with investigators, IRB's/EC's, contractors/Vendors and company personnel as needed.
• Bachelor of Science Degree, preferably in Life Science, Physical Science, Nursing or Biological Science.
• 3-5 years of working experience as a clinical research associate.
• Working knowledge of regulations and standards applied in clinical area and medical devices.
• Medical device experience required.
• Therapeutic area experience (ophthalmologic, not optometric) strongly desired.
• Strong knowledge, understanding and application of principles, concepts and practices of clinical investigations/studies.
• Strong organizational, analytical, oral and written communication skills.
• Technical writing skills.
• Knowledge of the application of requirements to new products and processes.
• Ability to collect and analyze data.
• Ability to develop innovative solutions to problems with minimal complexity.
• Ability to flexibly adjust to a dynamic working environment.
• Equipment: Must be able to operate personal computer, printer, telephone, facsimile, copier, calculator; and be familiar with Microsoft office products, software as required.
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
This position comes with enhanced benefits which include:
• 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%) *
• Paid sick days and vacation days*
Perks of being a Kelly employee:
• Weekly electronic pay
• Access to more than 3,000 online training courses though Kelly Learning center
• Online application system
• Never an applicant fee
*benefits to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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