Excellent Job Opportunity For Role: Clinical Research Associate At Alameda, Ca

Hello,
One of my medical client is looking for Clinical Research Associate (CRA) if you're interested or your skills matches please share with me your updated resume to [email protected]
Role: Clinical Research Associate (CRA)
Location: Alameda, CA - 94502
Duration: 12 Months on W2 (Possible for extension)
Type: 100% Onsite Office Role

• Participate in cross-functional clinical team(s) in the planning and execution of clinical trials.
• Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements.
• Clinical Operations Manager as needed
• Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), conducting User Acceptance Testing (UAT), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
• The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
• Conduct single or multi-center medical device clinical studies.
• May interact with RA/QA in responding to audits and FDA inquiries.
• Maintain and audit Trial Master File to ensure inspection readiness.
• Perform review of clinical data listings for completeness and accuracy, and escalate issues to the
• Responsible for shipping study devices and supplies to clinical sites and performing study device accountability.
• Ensures quality delivery of study deliverables within agreed budgets and timelines.
• Participate in the interim and final reviews of study data in preparation of regulatory submissions.
• Proactively and effectively communicate the status of clinical studies to management.
• Perform study site visits (SQV, SIV, IMV, COV), generate monitoring trip reports, and track resolution of action items.
• Participate in study start up activities.
• Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports).

Education And Experience

• Experience coordinating site initialization and site close
• CRITICAL to have direct Site Monitoring experience as that is what has been missing from the candidates already reviewed.
• Familiarity with data cleaning and database process (Queries)
• TMF upload experience is preferred.
• Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.
• CRO experience is not required now but may be in the future and industry experience is preferred.
• Specifically looking for monitoring experience on the sponsor side.
• Must have 5+ years of relevant experience in site monitoring, clinical project management, clinical trial practices and regulations.
• Basic MS Office with Outlook, Project, PowerPoint and Excel
• Minimum of 3 to 5 years of clinical experience within industry.
• Familiar with IRB (Institution Review Board) submission
• ICF (informed consent forms) revision exp.
• Experience editing/revising CRF "case report forms"
• BS degree in life sciences or equivalent with minimum 5 years of related experience, or MS degree in life sciences or equivalent with minimum 3 years of experience, or PhD with 2+ years of experience.
• Training PI staff
• HCI Guidelines

Skills

• Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
• Flexibility in daily activities.
• Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
• Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
• Proficient with Microsoft Suite.
• Working knowledge of GCP, Clinical and Regulatory Affairs.
• Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.

Thanks & Regards
Sai Kiran| Senior Recruiter
Email: [email protected]
Desk Number: 732-412-6999 Ext: 146
Direct Number: 732-913-3125