Address
Form of workUnder the direct supervision of the Principal Investigator and senior study staff, assists with the coordination and implementation of assigned Clinical Research trials.
- Assists with the submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files.
- Performs assigned activities related to Clinical Research studies including but not limited to screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes source documents and case reporting forms.
- Responsible for in depth knowledge of protocol requirements and Good Clinical Practice GCP guidelines.
- Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures SOP and internal and external regulatory agencies.
- Establish and maintain communications with Investigator, Sponsor and internal constituents.
- Performs other related duties as assigned or required.
- Bachelors degree required OR Associates Degree and 4 years of healthcare or research related experience.
- Certification in Human Subjects Protection, CITI Training must be obtained within 1 month of hire.
- Ability to assist the work on multiple projects. Experience in a team setting desirable.
- Medical terminology or basic research terminology preferred. DOT IATA Training preferred.
- Detail oriented person with the ability to collect, compile, and analyze information.
- Able to work independently on multiple tasks and manage time effectively.
- Excellent verbal, written, interpersonal and communication skills.
- Computer skills required Excel, PowerPoint and Word.
- Travel may be required.
