Clinical Records Representative
At a glance
Location: US-CA-Irvine Map
Posted: 04/21/2021
Closing: 05/20/2021
Degree: Not Specified
Type: Contractor
Experience: Not Specified
Job description
Our global medical device client has a Clinical Records Representative opportunity available. This is an onsite position, local candidates required. 

* Review and ensure accuracy and completeness of clinical study documents (e.g., EFS, pivotal) ensuring GDP and performing quality checks with limited supervision with limited direction
* 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 clinical data for completeness of study files
* May retrieve documents in support of internal and external audits utilizing knowledge of eTMF filing structure
* Incidental: May collate new study materials, create study binders, patient recruitment materials, and arrange shipment of materials to clinical sites

* At least one year of experience working with documentation; experience working with any electronic systems (ETMF)
* Must be okay with working in documentation
* Strict attention to detail

Additional Skills:
* Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
* Experience with TMF preferred
* Good written and verbal communication skills and interpersonal relationship skills
* Good knowledge and understanding of Edwards policies and SOP, and domestic medical device regulatory guidelines relevant to clinical study documentation
* Good knowledge of EW GDP (Good Document Practice) SOP requirements
* Ability to manage confidential information with discretion
* Strict attention to detail
* Ability to interact professionally with all organizational levels
* Must be able to work in a team environment under minimal supervision

* High School diploma or equivalent required; Bachelor's degree preferred
* 2 years of experience required - any type of clinical or laboratory experience that includes documentation work and experience with an electronic system; internship experience is fine

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Clinical Records Representative