Better Opportunities for a Better Career
St.Luke's-Roosevelt Hospitals, affiliates of Columbia University College of Physicians and Surgeons, is a 1,076-bed, full-service community and tertiary care hospital. St. Luke's-Roosevelt was formed in 1979 by a merger of St. Luke's Hospital, adjacent to the campus of Columbia University, and The Roosevelt Hospital, located two blocks west of Columbus Circle. The St. Luke's and Roosevelt Hospitals, established in 1846 and 1871, respectively, brought to their merger extraordinary records of medical "firsts" and commitment to their patients.
Roosevelt Hospital is seeking a NORDIC In-house Clinical Trial Associate:
This is an exciting opportunity to be a part of a fully funded clinical trial research network of study sites across the US and Canada. This individual is responsible for carrying out and following the directives of the NORDIC Chair and NORDIC Regional Project Coordinator within NORDIC Headquarters, and to help maintain an effective research Network to conduct multiple clinical studies. The In-house Clinical Trial Associate position responsibilities will include, but not limited to:
· Provides support to Regional Project Coordinator
· Assists with NORDIC Headquarters administrative tasks as directed
· Co-monitoring as required to assist in meeting data collection timelines or to review the investigator site binder, perform drug accountability and other tasks as deemed necessary.
· Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools
· Assists with clinical site initiation visits as needed, advising and training site personnel on NORDIC and regulatory requirements for study conduct including preparing reports
· Assists with site monitoring visits to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with GCP and ICH guidelines
· Provides site support for electronic data capture, monitoring data capture remotely, reviewing for completeness and consistency, and generating and resolving queries in between monitoring visits
· Assists in the termination of clinical studies through the oversight of clinical sites through data lock, resolving final queries and completing remote closeout visits
· Assist in answering protocol-related questions from study sites
· Other duties and responsibilities as assigned
The position works in conjunction with site Investigators and site Coordinators to develop ways to recruit and retain patients eligible for each study. NORDIC Headquarters resides within an academic teaching hospital in NYC and interaction with the parent healthcare departments is essential. The network has a website in development to support clinical trial functions.
Position will also interface with Industry sponsors, Data Coordinating and Biostatistical Centers (DCBC), clinical sites, and government sponsors including the National Institute of Health.
A Bachelor’s degree or higher is required with 2-5 years relevant clinical research experience. Strong knowledge of regulatory and clinical practices (GCP). Demonstrated aptitude and knowledge of clinical trials is essential. Ability to learn and integrate Neuro-ophthalmology therapeutic area into clinical trial tasks. Characteristics: Self starter, passion, energy, personal drive and motivation. Confidence to interact with physicians, administrators, and clinical site coordinators is needed. Multitasking with ability to move between projects and responsibility is essential.
Qualified candidates please send resume, with subject line “In-house Clinical Trial Associate” to:
Bernadette Farrell
NORDIC Regional Project Coordinator
Roosevelt Hospital
1000 10th Ave, 11-C01, INN
NY, NY 10019
Fax: 212-523-8808
Email: bfarrell@chpnet.org
