The Center for Behavioral Cardiovascular Health (CBCH) is an innovative research team looking for highly organized candidates who are excited to further develop their regulatory and translation skills in a patient-oriented, research setting. Ideal candidates will be able to adapt to a fast-paced environment with evolving responsibilities, workloads and work schedules. They will also be self-motivated and able to work effectively in high-stress conditions with tight deadlines.
Under the direction of the Regulatory Manager and the Director of Research, Administrative and Clinical Operations, the Regulatory Assistant is responsible for supporting the Regulatory Manager with regulatory tasks (IRB and HIPAA) across CBCH. S/he will be responsible for assisting in the completion of various regulatory tasks and compliance with internal and external policies and procedures. Additionally, the incumbent will be responsible for providing translation assistance across multiple grant-funded projects. S/he will translate documents (consent forms, questionnaires and other study-related materials) from English to Spanish, with special attention to research subject and patient literacy levels
Assist in the preparation of applicable sections of the Rascal Human Subjects (IRB) module;
Assist with the coordination of modifications, renewals and/or study closures for CBCH IRB protocols, with particular focus on Spanish translation and personnel modifications;
Organize and save stamped study materials to appropriate study folders;
Archive inactive and expired study materials for research studies;
Coordinate with faculty and staff to ensure compliance with conflict of interest completion, training requirements and other compliance reporting mechanisms.
Generate and maintain organizational charts and lists to increase efficiency and support regulatory compliance
Translate written documents from English to Spanish (consent forms, questionnaires, and any other study related materials) to match end-user literacy levels;
Review and analyze complex written documents;
Accurately translate style and tone of original documents;
Relay concepts and ideas between languages, specifically healthcare, medical and technical terms
The incumbent will perform other related duties as requested and required.
Requires a bachelor's degree or equivalent in education, training and/or experience, plus a minimum of two years of related experience.
Spanish fluency required.
Experience in oral and written translation and/or interpreting from English to Spanish.
Experience in a clinical and/or research setting.
Familiarity with University systems utilized for regulatory management (Rascal).
Must be highly organized, with excellent attention to detail and follow-up skills.
Must be competent in Microsoft Office and web browser programs.
Strong interpersonal and oral and written communication skills.
Must be able to work independently, as well as perform as part of a team.
Must demonstrate flexibility and willingness to adjust schedule to meet deadlines.
Strong commitment to equity, diversity and inclusion.
Must successfully complete systems training requirements.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 510396
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.