Clinical Operations Analyst
Irvine, CA Temporary $43.00 - $45.00/hr Remote

Job Description

The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.

The Clinical Operations Analyst will be a key contributing member of the dynamic Case Review Team, providing timely logistical support, analysis and tracking during patient screening and procedural case reviews for multiple transcatheter heart valve clinical trials.

Essential Job Functions/Key Responsibilities:
* Prepare templates for case review, assist with logistics and file case presentations
* Enter case review data into excel spreadsheets
* Perform quality/audit checks of case review data
* Creation of complex excel spreadsheets to track/analyze case review and CT data and metrics
* Assist with creation of templates for procedural case reviews
* Other miscellaneous case review tasks

Minimum Requirements:
* Bachelor's Degree and 3 years of previous hands-on clinical research related experience or experience in a medical related field with medical terminology knowledge

Preferred Qualifications:
* 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
* Demonstrated problem-solving and critical thinking skills
* Full knowledge and understanding of company's policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
* Advanced problem-solving skills
* Ability to manage confidential information with discretion
* Completes tasks in resourceful and effective ways
* Strict attention to detail
* Ability to interact professionally with all organizational levels
* 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 given with 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 environment and prevention of pollution under their span of influence/control

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

Job Reference: JN -062025-398029