Clinical Research Associate (CRA)

Role: Clinical Research Associate (CRA) - B

Location: San Diego, CA - 92121

Duration: 06+ Months on W2

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)
• Ability to train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, testing and shipping, data entry and query resolution
• 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
• Team player able to deliver on project timelines.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
• Other duties as assigned, according to the changing needs of the business.
  
  

Top 3 Skills

• 1) on-site and remote monitoring experience 2-5 years.
• 2) experience with study start up, monitoring, and close out activities
• 3) ability to work independently, get training done and able to hit the ground quickly.
  
  

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)

Ability to train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, testing and shipping, data entry and query resolution.

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)