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Franchise Clinical Coordinator
Ref No.: 18-04300
Location: irvine, California
Start Date: 04/17/2018
SUMMARY OF THE JOB

Under direct supervision, performs a variety of activities within the Clinical Research Cardiovascular programs in support of various clinical trials and projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES
Under general direction of Clinical Franchise Cardiovascular management, and in accordance with all applicable Regional, State and local laws/regulations and corporate Pharmaceutical procedures and guidelines, this position:
  • Provides general documentation support to project teams (Formatting, tracking, finalizing protocols, literature reviews, and other necessary study/project documentation).
  • Provides administrative support for Clinical Research Franchise Cardiovascular and BSDM, including
    • Training coordinator
    • Records management
    • Contract requests and due diligence
    • Periodic meeting scheduling/support
  • Processes and organizes purchase order and invoice requests through Pharmaceutical online accounts payable systems.
  • Assembles, distributes, and files critical study/project documents, as necessary.
  • Provides system support to Franchise (e-filing, CTMS, reporting, etc)
  • Assists with scheduling and organizing investigator and expert panel meetings, as requested.
  • Works with internal cross-functional representatives and external vendors (CROs, Core Labs, and/or consultants) to meet clinical program needs.
  • May actively participate in study team meetings and project updates.
  • May participate in process improvement activities within the department.
  • Responsible for communicating business-related issues or opportunities to next management level.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • May perform other related duties assigned as needed.

REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
  • Bachelor's Degree required, preferably in the sciences
  • 1-4 years of work related experience (i.e. clinical research experience)
  • Prefer medical device experience in the cardiovascular field

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
  • Ability to use PC and associated software.
  • Excellent PowerPoint, Word, Excel skills.
  • Excellent written and oral communications skills.
  • Ability to multi-task, excellent attention to detail, and organizational skills.
Working knowledge of Good Clinical Practices (GCP) is desirable