CCS Associates has more than 25 years of broad-ranging experience providing expert consulting services to government and industry clients concentrating on acquisition and analysis of scientific information and on providing support at key steps of drug development. We are highly qualified in regulatory affairs, clinical and preclinical studies management, quality assurance, data management, data analysis, scientific report generation, information research, technology assessment, and strategic planning. CCSA provides scientific and professional expertise in the treatment of chronic diseases, especially cancer. We are committed to quality, customized service, and protection of client confidentiality.
The CRA 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.
- 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 International Conference on Harmonization (ICH)/Good Clinical Practice (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.
- Working knowledge of SOPs along with Food and Drug Administration and ICH/GCP guidelines.
- Proficient in Word Office Suite
- 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.
- Has the ability to travel (up to 25% time), including international travel.
- BS/MS/RN or equivalent in scientific or health care field.
- Three years of pharmaceutical, clinical, or biological research experience with 1–3 years of CRA/CRC experience.
CCSA offers a full benefits package (medical, dental, vision, long-term health), life insurance, and a 401k plan.