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.*

Regional Clinical Research Associate (East)

Regional Clinical Research Associate (East) is responsible for all clinical trial-related monitoring/auditing activities, protocol review, Informed Consent, and case report form (CRF) and guidelines development. Assists in standard operating procedure (SOP) preparation and training as needed.

Responsibilities

  • Provides site management and monitoring support for sponsored clinical studies.
  • Performs on-site pre-study/qualification, initiation, routine, and close-out visits. Prepare site visit reports and provide assistance to site staff in resolving deficiencies.
  • Educates and trains site and study staff in management of sponsored studies, including assurance to regulatory and ICH/ GCP compliance.
  • Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
  • Assist in protocol, Informed Consent, and CRF design and review.
  • Develops and demonstrate understanding of and apply therapeutic area knowledge to assignments and project-related issues.
  • Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager.
  • Decisions are made independently and with some supervision from Senior Director, Research and Development or Project Manager.
  • Tasks are primarily intellectual and require exercise of 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.
  • Must be willing 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.
  • At least 3 years of pharmaceutical, clinical, or biological research with 1-3 years of CRA/CRC experience.

*Note: Incomplete applications (e.g., missing cover letter and/or writing sample) will not be considered. For the formal writing sample, if part of a multi-author publication, please explain what your contribution was.