Reporting to the Site Leader, the Site Coordinator coordinates and monitors activities related to all the National Institute of Health (NIH)/DAIDS clinical trials, COVID-19 trials and other grant-funded research conducted at the Bronx Prevention Center (BPC), a clinical trials center that is part of ICAP at Columbia University, but located in the south Bronx, including study initiation and protocol start up activities, regulatory, recruitment/retention, data management, and quality assurance /quality control activities. The Site Coordinator will closely collaborate with the CRS Leader, site Principal Investigators, site study investigators and Clinical Trials Unit (CTU) leadership and manage study staff in the implementation of study goals and objectives.
- In collaboration with the Site Leader and site Principal Investigators (PIs), develops day-to-day staffing plans, and complete logistics for the execution of study specific activities, including workflow, staff daily meetings, and on-site troubleshooting of study and staff issues, including staff feedback, training, and performance evaluations in compliance with all DAIDS, IRB requirements and other study requirements. 35%
- Reviews internal and external monitoring reports, data quality reports, data quality management plan and standard operating procedures (SOPs). Works with the site team to develop an effective and continuous quality improvement plan (CQMP) to ensure the soundness and efficiency of all operational processes related to study activities. 20%
- Ensures timely submission of protocol specific regulatory documents to the CUMC IRB and central IRB(s) and supervises the maintenance of up-to-date federally required essential documents. 15%
- Ensures that all team members are notified of all scheduled monitoring visits and audits, takes proactive measures to prepare for such audits, and provides input and required information during monitoring visits and audits to ensure successful outcomes. 10%
- Ensures timely collection and reporting of research information and data that is legible, accurate, complete, timely, as well as verifiable by internal and external reviewers while ensuring the safety of all study volunteers. 5%
- Perform other duties as assigned. 15%
- Bachelor’s degree or a comparable combination of education, training and experience
- Five years of related clinical trial 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.
- Experience in staff supervision and management
- Master’s degree in public health, nursing, medicine, pharmacy or other related degree
- At least 2 years research experience as a study coordinator of multicenter IND trials
- Holds a CCRC credential from ACRP or CCRP credential from SoCRA or other clinical research certifications accredited by the National Commission for Certifying Agencies (NCCA).
- Demonstrated supervisory / leadership experience leading a group of clinical trial staff.
- Demonstrated experience organizing and implementing disparate work flows to meet organizational schedules and requirements.
- Experience implementing HIV/AIDS research programs/studies preferred
- Experience working with an ethnically, culturally, and racially diverse environment
- Local travel required
- Out of town travel to twice yearly research network conferences