Under the supervision of the Site Manager, the Study Coordinator will collaborate and oversee all activities related to COVID grant-funded research conducted at designated Bronx Prevention Center (BPC) in the field and on site, including site initiation and protocol start-up activities, regulatory requirements, recruitment and retention plans and implementation, data management, and quality assurance and control activities. The Study Coordinator will work closely with the CRS Manager, CRS site Principal Investigator, and staff in the implementation of study goals and objectives.
1. Conduct all research activities in accordance with study protocol, standard operating procedures and other appropriate institutional regulations, procedures, and policies, including procedures to safeguard confidentiality of study participants. 10%
2. Prepare site for activation including set-up of research office, office systems and SOPs, etc 10% 3. Coordinate all aspects of the study to ensure site compliance with study protocol, all relevant procedures, policies and regulations. 10% 4. Oversee study staff on day to day activities of study implementation and administration. Participate in study implementation activities such as consenting participants, and QA/QC activities at the site. 10% 5. Schedule field staff and make sure that there is coverage as needed 10% 6. Coordinates the day to day field activities with the recruitment and research team out in the field daily in order to meet the study specific target, requirements and adjust accordingly 10% 7. In collaboration with the site investigators and study coordinators, ensure timely submission of protocol specific regulatory documents to the central IRB if applicable and/ or to the Columbia IRB. Maintain study regulatory files and communicate with the all the relevant IRBs for timely submissions and to ensure essential documents and regulatory documents are up to date 10% 8. In collaboration with the data manager and study team , ensure timely collection and reporting of research information and that data is verifiable by internal and external reviewers. 5% 9. Maintain confidentiality of study participants and adhere to principles of Good Clinical Practice (GCP) and ethics of human subjects research 5% 10. Attend staff meetings, study specific and other study related trainings as requested by the CRS Leader, CRS Coordinator and site Principal Investigator. 5% 11. Perform other duties as assigned. 5% 12. Coordinate vacations and days off with the other staff members to that proper recruitment and retention target are not disrupted 5%
Bachelor's degree or equivalent in education and experience plus three years of related experience
Knowledge of research data management and regulatory compliance.
Excellent clinical, organizational, interpersonal and communication skills.
Must be able to adapt to flexible schedule.
Proficiency in computer applications.
Meticulous attention to detail with the ability to multi-task.
Ability to work under pressure and react effectively to urgent situations.
Ability to work independently and as part of a team.
Master in Public Health or relevant field preferred
2 plus years as a study coordinator of multicenter IND trials.
An interest in/or experience with COVID related research
Experience working within an ethnically, culturally, and racially diverse environment
Local travel required
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 509197
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.