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

Date Posted: 7/13/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    7/13/2018
  • Job ID:
    865908

Job Description


Description: 
A Clinical Trial Management Associate 1 (CTMA 1) manages components of Phase 1 through 3 oncology clinical trials as a member of the clinical operations study team. 
The CTMA 1 provides administrative assistance in study implementation and the ongoing coordination of the clinical trial, facilitating the partnership between clinical operations, cross functional team, CRO partners, and clinical sites to achieve study goals. 
The qualified candidate has at least 1 year of relevant experience and either a Bachelors degree (scientific discipline preferred) or is a Registered Nurse; candidates must have strong Word, Excel, and PowerPoint skills. 
Candidates must take direction well and possess a collaborative demeanor. 
Strong organizational skills, attention to detail, and excellent verbal, written, interpersonal, and presentation skills are required. 
CTMAs must work well both independently as well as part of a team. 
Familiarity with routine medical / scientific terminology is required; experience in Oncology is preferred. 
The right candidate will have an understanding of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard operating procedures. Limited travel is required.

Specific activities may include: 
Tracking study-specific information utilizing databases, spreadsheets, and other tools; 
Development and/or detailed review of documents and standard forms (eg,, study protocols, informed consent, case report form, monitoring plan, status updates); 
Review of clinical study data and reports; 
Arranging meeting logistics, generating meeting agendas and minutes, and presenting at study meetings as required; 
Vendor management and oversight; 
Clinical site management, either functioning as a clinical site monitor or via oversight of vendor monitors, including performing routine data collection, source data verification, resolution of monitoring issues, and review of regulatory documents/files in relation to the protocol, regulatory requirements, SOPs and Monitoring Plan; 
Review and oversight of Trial Master File.
 

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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.