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Position Summary: We have an exciting opportunity to join our team as a Clinical Research Associate II.
In this role, the successful candidate will report directly to the Project Manager and the Program Director at the Coordinating Center of an NIH funded large-scale national clinical trial. The CRA will be part of the Coordinating Center NIH funded large-scale national trial aiming to enroll 1050 study participants in 60 centers to evaluate prolonged suppressive antiviral treatment to reduce complications of zoster/shingles of the eye. The CRA will work closely with study chair in order to understand study protocol from study investigators and coordinators. CRAs will provide overall monitoring activities for the study.
Communicate frequently with enrolling centers to assist them as needed in maintaining complete subject follow-up .Collaborate with the statistics, data management teams and enrolling centers to resolve outstanding forms and data queries; all site contacts regarding late forms or highly queried forms will be made by Coordinating Center staff using information provided by the statistics and data management teams. Assist with yearly progress report to NIH and DSMB Meeting Preparations Close out enrolling centers Contribute to monthly newsletter and FAQ documents
Oversee CTA activities related to collection of signed protocol pages from each centers principal investigator. Oversees the conduct of central review and monitoring of at least 10% of the Case Report Forms and related study documents against the copies of source documents from enrolling centers to verify data recorded on CRFs with CRA. Monitors enrolling centers by conducting on location and remote reviews drug accountability logs, source documentation storage and other regulated processes at enrolling centers Develops and implements corrective action plan for enrolling centers with discrepancies between source documents and CRFs Correspond with local coordinators regarding corrective measures including poor recruitment, retention of patients, errors in CRF, or excessive edits. Act as a clinical trial resource for research coordinators. Respond to clinical calls related to protocol questions, study eligibility, follow-up methods for missed visits, lost patients, handling SAEs, etc. Need to handle and/or refer questions about findings that may or may not meet the primary and secondary endpoints. Develop knowledge of protocol and study and know when to contact medical doctor leaders. Follow up on HelpLine contacts by enrolling centers to ensure that the site understood and implemented the HelpLine instructions
Develops and executes Coordinating Centers centralized and onsite monitoring plans. 2 Develops teaching tools and brochures for study participants and their families Attend training sessions and assist in training of enrolling center coordinators 3 Leads webinars and in certifying sites for enrollment by reviewing and approving all necessary documents prior to centers enrolling study participants 4 Reviews each enrolling centers individualized consent form for required elements according to the Department of Health and Human Services and Federal Drug Administration regulations, including HIPAA authorization in the US, prior to sites submitting to their IRB; 5 Respond to IRB queries from enrolling center after consultation with PI. Oversee CTA activities related to the review of signed, dated CV and license of principal investigator and sub investigators. 6 Reviews and prepares technical documentation including study protocols, informed consents, case report forms, and study training documents
Minimum Qualifications: To qualify you must have a Bachelors Degree with a minimum of five (5) years of progressively responsible related experience coordinating clinical/research trials studies. Effective verbal and written communication skills are required. Advanced knowledge of personal computer software such as Microsoft Office including Word, Excel, Powerpoint and Access. Highly motivated with a desire to learn more about shingles of the eye.
Preferred Qualifications: A Masters Degree is preferred; EDC and CTMS experience desirable; CCRA certification strongly desired. clinical trial experience in an academic healthcare setting or industry setting working as a clinical monitor 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.
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Internal Number: 62545071
About NYU Langone Health
NYU Langone Health, a world-class patient-centered integrated academic medical center, is one of the nation's premier centers for excellence in clinical care, biomedical research, and medical education. Located in the heart of Manhattan, NYU Langone is composed of four hospitals – Tisch Hospital, its flagship acute care facility; Rusk Rehabilitation; the Hospital for Joint Diseases, one of only five hospitals in the nation dedicated to orthopaedics and rheumatology; and Hassenfeld Children's Hospital, a comprehensive pediatric hospital supporting a full array of children's health services across the medical center – plus the NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center's tri-fold mission to serve, teach, and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to www.nyulangone.org.