Clinical Research Associate II
Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health and Information Technology to both private industry and government agency clients. TRI is currently seeking a Director, Data Management to join our Bethesda, MD team.
- Provides site monitoring and site management services for sponsored clinical trials.
- Conducts on-site pre-study/qualification, initiation, routine, and close-out monitoring visits, following corporate and/or sponsor Standard Operating Procedures (SOPs) and other requirements.
- Performs on-site and remote source document verification, data review, study product reconciliation, and regulatory binder review. Prepares visit reports and provides assistance to site staff in resolving deficiencies.
- Develops and demonstrates understanding of assigned therapeutic areas and applies knowledge to study and project-related issues.
- Educates and trains site and study staff in study conduct, including compliance with FDA and ICH/GCP guidelines.
- Collects and reviews regulatory documents in compliance with guidelines and standards.
- Assists in Protocol, Informed Consent, and CRF design and review.
- Appropriately resolves issues related to site monitoring and management with guidance from the Project Manager.
- Decisions are made independently and with some supervision from Line or Project Manager.
- Working knowledge of SOPs along with Food and Drug Administration 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
- Has the ability to travel (up to 25% of the time), including international travel
- BS/MS/RN or equivalent in scientific or healthcare field
- Three years of pharmaceutical, clinical, or biological research experience with 1–3 years of CRA/CRC experience
Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.