Under the direction of the Research Associate and Principal Investigator, the Research Assistant will create and update informed consent forms and submit regulatory documents to HIC; keep track of changes in regulatory documents and maintain regulatory files; prepare documents for audits and review by sponsors, regulatory agencies, and internal or external review boards; work with section clinical study coordinator to ensure compliance with internal and external regulatory agencies; assist with coordination of multiple single-center and multi-center clinical trials for the Viral Hepatitis Program; oversee shipping, receipt, storage, and dissemination of study materials; maintain supply inventory required for research protocols.
Posting Position Title: Research Assistant 2 HSS
University Job Title: Research Assistant 2, HSS
Work Week: Standard (M-F equal number of hours per day)
Required Skill/ability 1: Demonstrated ability to manage multiple clinical studies including knowledge of regulatory processes and protocols, and to multi-task juggling, competing research demands.
Required Skill/ability 2: Ability to communicate with IRB, regulatory agencies, and review boards and assist in writing grant proposals and protocols, revisions and/or amendments, progress reports, and research documentation.
Required Skill/ability 3: Excellent interpersonal communication, organization and planning skills as well as strong computer skills with Microsoft Word, Excel, PowerPoint and proficiency with clinical data storage programs such as EPIC or OnCore.
Required Skill/ability 4: Demonstrated ability to work independently with sound judgment, work efficiently and maintain confidentiality, and manage a broad variety of duties and shifting priorities in a changing environment. Must be organized and meticulous with details.
Required Skill/ability 5: Demonstrated ability in shipping biological substances, Category B via eShip-Global (or similar program).
Preferred Education, Experience and Skills: Prior experience managing clinical studies; working knowledge of Yale clinical research policies and procedures including but not limited to the regulations of the Yale Human Investigation Committee (HIC). Access experience and familiarity interfacing with Yale-based clinical data storage programs.
Required Licenses Or Certifications:
Two years of related work experience in the same job family and a Bachelor's degree in a related field; or an equivalent combination of experience and education.
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.