Careers

 
CCSA seeks talented, qualified employees in all of our operations. CCSA offers a full benefits package (medical, dental, vision, long-term health), AD&D, life insurance, and 401k plan. CCSA is an Equal Employment Opportunity Employer. For consideration, send resume, cover letter, and formal writing sample (where requested) to careers@ccsainc.com.

Clinical Research Associate (US-based, East Coast)

Division: Research & Development
Department: Clinical Monitoring
Job Classification: Contract
Reports to: Project Manager, Research & Development

Summary: Provide clinical trial-related monitoring activities including remote and on-site visits to the US sites participating in investigational studies.

Essential Duties and Responsibilities:

  • Provides site monitoring support for sponsored clinical studies.
  • Performs on-site and remote initiation, routine, and closeout visits.
  • Prepares site visit reports and provides assistance to site staff in resolving deficiencies.
  • Educates and trains site and study staff in management of sponsored studies, including regulatory and ICH/GCP compliance.
  • Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
  • Develops and demonstrates understanding and application of therapeutic area knowledge to assignments and project-related issues.
  • Appropriately resolves issues related to trial monitoring and management with guidance from the Project Manager, Clinical Monitoring.
  • Makes independent decisions with some supervision from the Senior Director, Research & Development, or the Project Manager, Research & Development.
  • Performs primarily intellectual tasks and exercises discretion and independent judgment.

Qualifications:

    • Working knowledge of SOPs along with FDA and ICH/GCP guidelines.
    • Good communication, organizational, and writing skills.
    • Develops and applies efficient computer tools to carry out job functions.
    • Attention to detail; ability to work in a team environment.
    • Dependable; assumes responsibility and accepts, supports, and positively facilitates change.
    • Ability and availability to communicate with sites in different US time zones.
    • Willingness to travel.
  • Working knowledge of Microsoft Office suite
  • Working knowledge of clinical trials electronic tools (CTMS, eTMF, EDC, IRT).

Education and Experience:

  • BS/MS/RN or equivalent in scientific or health care field.
  • At least 3 years of pharmaceutical, clinical, or biological research with 2 years of Clinical Research Associate experience in oncology.

Clinical Research Associate (US-based, West Coast)

Division: Research & Development
Department: Clinical Monitoring
Job Classification: Contract
Reports to: Project Manager, Research & Development

Summary: Provide clinical trial-related monitoring activities including remote and on-site visits to the US sites participating in investigational studies.

Essential Duties and Responsibilities:

  • Provides site monitoring support for sponsored clinical studies.
  • Performs on-site and remote initiation, routine, and closeout visits.
  • Prepares site visit reports and provides assistance to site staff in resolving deficiencies.
  • Educates and trains site and study staff in management of sponsored studies, including regulatory and ICH/GCP compliance.
  • Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
  • Develops and demonstrates understanding and application of therapeutic area knowledge to assignments and project-related issues.
  • Appropriately resolves issues related to trial monitoring and management with guidance from the Project Manager, Clinical Monitoring.
  • Makes independent decisions with some supervision from the Senior Director, Research & Development, or the Project Manager, Research & Development.
  • Performs primarily intellectual tasks and exercises discretion and independent judgment.

Qualifications:

  • Working knowledge of SOPs along with FDA and ICH/GCP guidelines.
  • Good communication, organizational, and writing skills.
  • Develops and applies efficient computer tools to carry out job functions.
  • Attention to detail; ability to work in a team environment.
  • Dependable; assumes responsibility and accepts, supports, and positively facilitates change.
  • Ability and availability to communicate with sites in different US time zones.
  • Willingness to travel.
  • Working knowledge of Microsoft Office suite
  • Working knowledge of clinical trials electronic tools (CTMS, eTMF, EDC, IRT).

Education and Experience:

  • BS/MS/RN or equivalent in scientific or health care field.
  • At least 3 years of pharmaceutical, clinical, or biological research with 2 years of Clinical Research Associate experience in oncology.