Clinical Records Rep

Ledgent Technology; Irvine (CA); On-site; USD 32,959 - 46,941; Full time

Job summary

A staffing agency is seeking a Clinical Records Representative in Irvine, CA, for a 9-month duration. The role involves ensuring the accuracy and completeness of clinical study documents, organizing and archiving data, and supporting audits. The ideal candidate has a high school diploma and 2-4 years of relevant experience, with strong computer and communication skills essential. This position offers an opportunity to work in a team-focused environment with strict attention to detail.

Qualifications

• 2-4 years of experience in a relevant field required.
• Basic understanding of clinical study documentation policies.

Responsibilities

• Ensure accuracy of clinical study documents.
• Organize documents in eTMF and/or CTMS.
• Support team during audits.

Skills

Good computer skills including MS Office Suite

Good written and verbal communication skills

Ability to manage competing priorities

Ability to work in a team environment

Attention to detail

Education

H.S. Diploma or equivalent

Job description

Clinical Records Rep

Duration - 9 Months
Location - Irvine, CA 92606
Max Pay - $29

Overview

The main function of a clinical records representative is to ensure accuracy and completeness of documents for clinical studies.

Responsibilities

• Review and ensure accuracy and completeness of clinical study documents (e.g., EFS, pivotal) ensuring GDP and performing quality checks with limited 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
• Support team members during internal and external audits
• Other incidental duties: May maintain and track study supplies

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
• Basic knowledge and understanding of Edwards policies and procedures relevant to clinical study documentation
• Basic knowledge of EW GDP (Good Document Practice) SOP requirements
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to manage competing priorities in a fast paced environment
• Ability to interact professionally with all team organizational levels
• Must be able to work in a team environment, including inter-departmental teams
• Ability to Provide feedback in a professional, direct, and tactful manner

Education and Experience

• H.S. Diploma or equivalent Required
• 2-4 years of experience

EEO statement: 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.