Clinical Trials Management Associate I in Foster City, CA at Apex Life Sciences

Date Posted: 6/14/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    6/14/2018
  • Job ID:
    858418

Job Description


Description:

  • Must meet all requirements for Clinical Project Assistant position and have demonstrated proficiency in all relevant areas.
  • Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
  • Monitors fairly routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
  • Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
  • May assist in compilation of investigator brochures under close supervision.
  • May resolve routine monitoring issues.
  • Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
  • Travel is required.
  • Excellent verbal, written, interpersonal and presentation skills are required.
  • Must be familiar with routine medical/scientific terminology.
  • Must be familiar with Word, PowerPoint, and Excel. Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
  • Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
  • Must be able to contribute to SOP development.

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 employeeservices@apexsystemsinc.com or 844-463-6178.