We are searching for team members with a passion for Bio-pharmaceutical who are energetic, flexible, and quick-learners. Your daily responsibilities would include, but are certainly not limited to, making decisions and preparing appropriate documentation according to FDA/ICH/GCP regulations, communicating and coordinating with multiple internal teams and study sites to ensure all aspects of the trial are operating under the above mentioned regulations, and working with members of the Clinical and TMF Operations team to prepare our Trial Master File for regulatory authority inspections.
As this industry is dynamic, you must be easily adaptable to change and able to learn and perform new tasks quickly and accurately. This is an office based position in our Raleigh, NC office.
Experience in scientific research and/or clinical trials
Skills and Competencies Required:
â¢Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; previous interaction with operational project teams and investigative sites preferred
â¢Ability to adapt to a changing environment and handle multiple priorities
â¢Detail and process oriented
â¢Superb organizational and time management skills
â¢Flexible and adaptable to a developing work environment; willingness to learn
â¢Positive attitude and approach
â¢Excellent communication skills, oral and written
â¢Self-motivation with the ability to work under pressure to meet deadlines
â¢Works well independently as well as in a team environment
â¢Interact with internal and external sites and vendors with high degree of professionalism and discretion
â¢Computer proficiency (MS Office - Word, Excel, Power Point), aptitude for training, capable of operating standard office equipment and learning new systems