Specialist I

Job Description

Supports initial review, creation, and set up of study documentation to prepare source for timely study delivery with a focus on expedited study start-up. Ensures source documents are set up in a timely manner so as to not delay study start-up. Follows a multi-step procedure to ensure data source integrity. Ensures that the site-level team is aware when the source is set up and completed at the project level. Review and comprehend the protocol and any other supporting material or guidelines. Supports new sites in the process of acquisition to ensure harmonization in source. Demonstrates flexibility and willingness to work in multiple systems and manage sources in multiple formats. Assist new hires in completing and submitting all required research documentation and training by their deadlines. Communicate with site-level staff regarding amendments and changes to the source. Communicate internally with the source team regarding source status and changes to the source. Adhere to safety and compliance regulations. Other duties as assigned. Qualifications Required Skills/Abilities: Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone. Demonstrated verbal, written, and organizational skills. Demonstrated interpersonal and communication skills. Demonstrated ability to work as a team player. Demonstrated ability to read, write, and speak English. Demonstrated ability to multi-task. Demonstrated ability to follow written guidelines. Demonstrated ability to work independently, plan, and prioritize with some guidance. Demonstrated ability to be flexible/adapt according to the needs of the clinics prioritization. Must be detail-oriented. Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued, and/or praised. Demonstrated understanding of ICH, GCP, and FDA regulatory requirements. Education and Experience: Bachelordegree with 1 year of relevant experience in the life science industry OR Associate degree with 2 years of relevant experience in the life science industry OR High School Graduate and/or technical degree with a minimum of 3 years relevant experience in the life science industry