Clinical Research Associate (RE-12452942) Hayward, California
Principle Responsibilities and Duties:
• Supports required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form development, IRB submissions, investigator agreements, informed consent form development, site selection and communication with clinical trial sites regarding all logistics including contract agreements, support materials and training
• Provides in-field clinical support for clinical trials to facilitate best practices during use of the company’s medical devices in accordance with the company’s SOPs and all applicable regulations during clinical investigations and post-market studies
• Performs or collaborates on required in-trial tasks that include, but are not limited to: communications with clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements
• Evaluates and analyzes clinical trial data to facilitate completion of clinical trial reporting requirements, including report writing, FDA and manuscript submissions
• Verifies, reviews and tracks CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data; ensure that data changes are properly implemented and captured in the database or data system
• Assists in tracking study specific payments
• Provides support in tracking clinical/non-clinical supplies
• Provides operational or work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed
• Collaborates on project teams, primarily with the Clinic, Research and Development, Advanced Development, Marketing, Regulatory Affairs and Quality Assurance
• Leads or collaborates on technical writing projects which include white papers, abstracts, manuscripts, and literature reviews
• Works on projects of moderate-to-high degree of difficulty in which analysis of situation or data requires review of identifiable clinical factors and preparation for or recommendation of the next steps in the clinical process
Education / Training:
• Bachelor’s degree in a health profession, science or engineering field. Masters degree desirable.
• At least 2 years of on-going clinical trials experience in the medical device industry. Experience in the cosmetic/aesthetic field is preferred.
• Demonstrated proficiency in knowledge of GCPs and knowledge of other pertinent regulatory requirements.
• Basic knowledge of medical terminology.
• Ability to effectively work independently
• Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook) and data management experience.
• 20%-40% travel required.