NYU School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on Facebook, Twitter and Instagram.
The Senior Research Coordinator will work collaboratively with the Principal Investigator (PI), study investigators, the Senior Project Manager, research team, sponsors and others to ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPPA and required obligations to behavioral and clinical research. The Senior Research Coordinator will provide daily project management and assist with supervision of research staff and is responsible for managing study goals, timelines, resources, and reporting in conjunction with the Principal Investigator. The Sr. Research Coordinator is the team liaison to internal and external parties, including NYU OSR departments, Pharmacy, monitors, clinical staff and others. The Sr. Research Coordinator will perform all study tasks including recruit participants, conduct study visits, collect data, and perform all study activities as appropriate. The Senior Research Coordinator is expected to work with a high level of independence.
Research Project Coordination and Management: Develop study-specific project plans and SOPs, from study initiation through recruitment close out and final reporting; manage timelines, resources and project milestones in conjunction with PI, project team and sponsor. Provide day-to-day project management for research as assigned including protocol compliance, staff supervision, participant management, data quality, problem resolution and leadership and coordination of the study team. Be familiar with Research Navigator, CRMS and other NYU systems as well as Epic electronic system.
Protocol Development and Compliance: Develop and maintain IRB and FDA documentations. Ensure that study activities are carried out in accordance with the protocol, HIPAA and GCP, including but not limited to participant recruitment & screening, study intervention, medication documentation and management, participant research visits, follow-up, and required documentation. Demonstrate thorough knowledge of study rationale, inclusion/exclusion criteria, and procedures associated with the study.
Staff supervision: Assist with staff supervision as assigned, including assisting with annual reviews, documentations for any disciplinary action and recognition, in coordination with functional leadership. Develop staff trainings for research projects.
Participant management: Develop study-specific participant recruitment and retention plans in conjunction with PI and project team; monitor goals and trouble-shoot recruitment/retention challenges. Recruit and screen patients for eligibility, completing necessary questionnaires, assessments and paperwork. Maintain patient confidentiality. Track participant flow through the study and update tracking logs in an accurate and timely manner. Contact participants to schedule them for study visits and send retention letters as needed. Manage the participant payment system for the project(s), including maintenance of the reimbursement payment system, documentation of participant compensation, and weekly review with Sr. Project Manager.
Research Visits: Conduct participant study visits, including scheduling, clinical assessments and documentation.
Data Management & Integrity: Review entered data, resolve data queries, and obtain missing information. Document all data accurately and according to protocol. Manage REDCap and TrialMaster databases including assisting with programming data collection instructions, user management, generating reports, and implementing edits to forms. Track and document shipments and storage of biological specimens.
Reporting and Communication: Communicate with PI and Sr. Project Manager regarding study operations and achievement of study goals. Provide PI and other team members as appropriate information regarding protocol deviations, safety events, and data queries. Assist in preparation of study reports, including progress reports to funding agencies and reports to the Data Safety Monitoring Committee when required. Gather and prepare information as requested for IRB submissions. Participate in national and local conference calls and meetings with collaborators. Collaborate with PI and team members on the dissemination of research findings, including publications and presentations, as appropriate.
Quality Assurance: Conduct regular checks of ICF, source documents, study data and other study documentation to ensure that the project is in compliance and that necessary corrections to documents or processes occur in a timely manner. Coordinate with internal and external monitors/auditors.
Team Leadership: Establish and maintain positive relationships with study team members, NYU medical center cores and units, internal and external stakeholders, sponsors, and ancillary staff. Coordinate study activities through open communication with Research Assistants, PI, clinical staff and external site staff.
Problem Resolution: Identify, respond to, and participate in the resolution of potential and actual problems in study operations and participant activities.
Participate in special projects and performs other duties as assigned.
To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related discipline. Minimum of four years of progressively responsible related experience coordinating clinical/research trials studies. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective oral, written, communication, interpersonal skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Ability to work and make decisions independently. Time management skills and ability to multi task. Strong understanding and knowledge base of coordination requirements associated with clinical/research trials. Ability to identify, analyze and solve problems; ability to work well under pressure.
Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines). Knowledge of basic medical terminology is preferred.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents.
NYU School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online. If you wish to view NYU School of Medicine's EEO policies, please click here. Please click here to view the Federal 'EEO is the law' poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.
Please See Above
Internal Number: 69572705
About NYU Langone Medical Center
NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. Included in the 200+ locations throughout the New York area are five inpatient locations: Tisch Hospital, its flagship acute-care facility; Rusk Rehabilitation, ranked as one of the top 10 rehabilitation programs in the country; NYU Langone Orthopedic Hospital, a dedicated inpatient orthopedic hospital with all musculoskeletal specialties ranked top 10 in the country; Hassenfeld Children's Hospital at NYU Langone, a comprehensive pediatric hospital supporting a full array of children's health services; and NYU Langone Hospital—Brooklyn, a full-service teaching hospital and level 1 trauma center located in Sunset Park, Brooklyn. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute–designated cancer center, and NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history.