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Senior Clinical Oversight Specialist
6 days ago
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Clinical Research Associate
1 month ago
Job Title : Clinical Research Associate (CRA) - B
Location : San Diego CA - 92121
Duration : 06 Months Contract
Job Description:
- This role is 100 percent onsite-long term position. Not Remote or Hybrid Our focus is on local candidates who want to work 100% in person and have 2-5 years previous clinical research experience.
- On-site and remote monitoring experience 2-5 years.
- Experience with study start up, monitoring, and close out activities.
- 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)
