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.
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.
- 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.
- 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.