Clinical Research Associate
Posting ID: JP-002179259
Primary QMS Responsibilities:
• Develop and write study protocols, monitoring plans, case report forms, informed consent forms, and other required documents for clinical studies.
• Conduct site qualification, selection, initiation, monitoring, and closeout visits in compliance with GCP and approved protocols; write site visit reports timely.
• Negotiate budgets and prepare contract agreements with study sites, vendors and CROs, as applicable.
• Provide training to study sites; review study site documents (e.g., regulatory documents, investigational product accountability logs and source documents).
• Maintain effective, professional, timely, and consistent communications with clinical site PIs, coordinators and other site personnel.
• Establish and update various databases for clinical study monitoring and tracking.
• Identify and report issues, problems or any protocol deviations that could affect the study results and completion timeline; propose solutions to the Director.
• Create, update, and maintain study TMFs for completeness, compliance and accuracy.
• Ensure timely completion of the clinical deliverables according to project timelines.
• Review invoices received from sites and maintains accurate accruals.
• Prepare clinical study reports and relevant sections of regulatory submissions.
• Ensure studies are conducted in accordance with GCP, US FDA regulations and OUS IVD regulations (as applicable).
Primary Non-QMS Responsibilities:
• Perform other duties and projects as assigned.
• Approximately 20-30% travel is required.
Education and/or Experience
• Minimum Bachelor’s Degree, preferably in a life science or health science discipline.
• Minimum 1-2 years of related experience, preferably including clinical research and clinical operations experience.
• Experience working in IVD clinical studies highly preferred.
ivd, CRO, TMF
Additional Skills & Qualifications:
• Computer software skills (e.g., MS Word, Excel and PowerPoint experience).
• Strong attention to detail, self-motivation, and good organizational skills.
• Ability to multi-task and ability to work both as part of a team and independently.
• Proactive approach, with high sense of urgency and results orientation.
• Progressive thinker, innovative and open-minded.
• High levels of integrity, intellectual honesty and maturity.
• Knowledge of FDA requirements for clinical validation and CLIA waiver.
• Knowledge of ICH GCP.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
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.
Recruiter: Kristyn Snow
Phone: (650) 825-2953