In House CRA II
ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a In House CRA II position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its Florida-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.
- 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 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.
- 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
- 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.
Skills and Requirements:
- 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Maya Smith at + 267-405-6995 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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