Clinical Trial Associate - CA in San Diego, CA at Apex Life Sciences

Date Posted: 8/9/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    San Diego, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/9/2018
  • Job ID:
    875821

Job Description


Our client, a leader in the pharmaceutical field, is seeking a Clinical Trial Assistant. 

Prerequisites:

  • Completed BA/BS in directly-relevant discipline or equivalent experience required
  • At least 2 years experience as CTA (or comparable operating experience) in pharmaceutical or CRO.

Summary/Scope: 

The Clinical Trials Associate (CTA) is involved in the conduct of the study and interfaces with the Study Manager and the Study Team. The CTA also supports the Study Team by creating and distributing study team materials, tools and documents.

Responsibilities will include, but are not limited to, the following:

  • Support the Study Team to select potential investigators and assess their interest in the study
  • Communicate with the sites through direct contact and other tools such as newsletters as appropriate per study requirements
  • Track study progress in CTMS including patient enrollment and patient status
  • Oversight of Monitoring Visit Report review for CROs
  • Support study data as the EDC administrator and by tracking CRFs and queries as appropriate for insourced studies
  • Process and track payments to vendors and study sites as appropriate
  • QC review of ICFs returned from the sites.
  • Investigational Product reconciliation.
  • Financial Reconciliation at the close of studies Support the Study Manager in creating, updating and tracking MS Project study plans Collecting, quality review and submitting documents to the TMF
  • Performing quarterly QC of TMF as appropriate
  • Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors
  • Generate, finalize and distribute study team agendas and meeting minutes
  • Assist with generating the CSR appendices and participate in SOP and WP development Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives

Skills/Knowledge Required:

  • Completed BA/BS in directly-relevant discipline or equivalent experience required
  • At least 2 years experience as CTA (or comparable operating experience) in pharmaceutical or CRO required
  • Computer skills - MS office suite CTMS (Celtrak)
  • Knowledge of databases - preferred - EDC (Medidata), IVRS (Endpoint)
  • Efficient at meeting planning / generating minutes Understanding / familiarity with drug development and process and Pharma Strong Verbal and written communications skills
  • Self starter / proactive Ability to work independently
  • Good listener / problem solver Ability to prioritize and multi-task and demonstrate flexibility and attention to detail
  • Familiarity with ICH / GCP and regulatory guidelines/directives
  • Team player and ability to build relationships
  • Strong organizational skills
  • Proficient at Vendor / site payment process Knowledge of medical/scientific terminology
  • Cross cultural awareness

Key Competencies:

  • Commitment to quality
  • Works efficiently
  • Demonstrate adaptability and flexibility
  • Acts with integrity Works independently
  • Shows work commitment Prepares written communication
  • Uses technical / functional expertise
  • Fosters teamwork
  • Proactive behavior
  • Listens to others

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.