Clinical Research Associate
6-month contract
Onsite in San Diego, CA
Responsibilities:
- Carry out assigned functions applying knowledge and skill in an accurate, timely manner.
- Apply knowledge of FDA regulations to site monitoring and clinical study design duties.
- Monitor and maintain necessary supplies, with approval by senior department staff.
- Maintain effective, professional, timely, and consistent communications with clinical sites both in person, and via all available correspondence media (telephone, email, web, etc.)
- Support and/or lead clinical research study start up activities (includes creation of study binders, study logs, work instructions, case report form, and other study related materials)
- Study monitoring (includes assessing the familiarity of the site personnel with the protocol, procedures and investigational product, assessing protocol compliance and investigational product accountability as applicable, source document verification, identifying protocol deviations, writing queries, writing monitoring reports, notes to file, and other documentation as necessary)
- Independent site management skills to assist with study problem identification and solving, and ensure timely study progression
- Understanding of clinical research activities including tasks associated with study start up, interim monitoring, close out, data collection and central files
Qualifications:
- Bachelor's degree in science-related field
- 2+ years of Clinical Research Associate experience
- Experience with both onsite and remote monitoring