Sr. Clinical Research Rep in Irvine, CA at Apex Life Sciences

Date Posted: 8/7/2018

Job Snapshot

  • Employee Type:
  • Location:
    Irvine, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Medical Device Company in Orange County wants to hire a Sr. Clinical Research Rep!


Responsible for efficient processing and quality check of all study documents.

Support and organize the preparation of Clinical Study binders •

Supervision of clinical study applications/submissions to Ethical Committees and Competent Authorities as an administrative support function to the Study Managers; &bull

Support the Study Managers upon request from study managers based on project needs; &bull

Responsible for all document archiving; & Control document validity and compliance (i.e. insurance certificates, etc.)

Organization of meetings related to clinical investigations such as Clinical Event Committees, Data Safety Monitoring Boards, Executive Committees and Steering Committees

CTMS support

Support clinical department on all business needs

Organize and document (paper and LMS) together with Clinical Managers/Directors employees trainings and all internal meetings

Manage all administrative aspects related to the Clinical Programs Europe THV in term of clinical study cost accountability

Conduct payment overviews (cost lists and invoices) and issue payments upon request 

Conduct periodic audits of documentation and may participate in internal master file audits

Provide coaching and training to lower level employees

Interact with clinical sites to resolve more complex device accountability issues

Provide training and technical support for internal and external users

Required Education and Experience:

BS/MS and 6 years previous related 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

Preferred Experience:

Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) 

CCRA and/or CCRP Certification

Please send resumes to

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.