Job Opportunity for Clinical Operations (Remote)

Role: Sr, Clinical Operations

Location: Irvine, CA 92614 (Remote)

Duration: 18 Months on W2

Notes: Remote role - will need to be onsite at the beginning for training.

Job Functions:

• Prepare templates for case review, assist with logistics, and file case presentations.
• Enter case review data into excel spreadsheets and Perform quality/audit checks of case review
• Provide administrative assistance for the Global Case Review Team to help support multiple transcatheter heart valve clinical trials. And Transcribe notes from case review calls.

Required Education/Skills/Experience:

• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
• Excellent written and verbal communication skills and interpersonal relationship skills
• Ability to work in a fast-paced environment and work flexible hours to meet the pace and demand of case review. And Demonstrated problem-solving and critical thinking skills
• Full knowledge and understanding of procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
• Advanced problem-solving skills and manage confidential information with discretion
• Must be able to work in a team environment, including inter-departmental teams, with supervisory guidance provided as needed in the execution of routine tasks
• General instructions are given with the assignment of new lines of work or complex special assignments
• Adhere to all EHS rules and requirements 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

Education and Experience:

• Associates Degree - required, 2 years of related experience
• Medical Terminology, clinical trial, clinical research experience - preferred