Here are the job position details for your review:

Job Title: Clinical Operations Analyst
Pay Rate: $30 to $31/HR
Duration: 12 months
Location: Orange County, CA (Onsite)

We are looking for Clinical Operations Analyst.

Summary:
As the Clinical Device Management Representative, you will assist with device processes associated with clinical trials, ensure compliance with regulations, and support the inventory management lifecycle.

Responsibilities include-

• Ensure clinical sites are sufficiently set up and stocked with trial supplies and track their lifecycle in related systems/tools under general supervision
• Organize and archive documents and data in eTMF (electronic trial master file) and/or CTMS (clinical trial management system) ensuring compliance with internal procedures and regulatory guidelines
• Review and ensure GDP accuracy and completeness of clinical study documents and perform quality checks with increased complexity under general supervision
• Retrieve and review clinical documents for completeness of study files under general supervision
• May process transactions under the supervision of senior team members

Minimum Requirements:

• High School Diploma or equivalent with 2 years of previous related clinical research experience OR
• Bachelor’s Degree in a related field

Preferred Qualifications:

• Experience with ERP software (i.e., JD Edwards), Salesforce.com, electronic Trial Master File (Veeva Vault), and CTMS (Clinical Trial Management System)
• Experience with inventory and/or supply chain management

Additional skills:

• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Good written and verbal communication skills and interpersonal relationship skills
• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
• Good problem-solving and critical-thinking skills
• Substantial knowledge and understanding of client policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control

Job Type: Contract

Salary: $30.00 - $31.00 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Please provide your email address.

Education:

• High school or equivalent (Required)

Work Location: In person