PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
The Research Project Coordinator provides regulatory support for a large prenatal and birth cohort study. The incumbent prepares and edits study materials including study protocols, informed consent forms, and study-related patient materials. S/he submits new applications, continuing reviews, amendments, unanticipated problems, and protocol deviations. The incumbent serves as the primary liaison with the IRB, promptly addressing all pre-review and committee comments. S/he serves as a resource to the entire study team as well as collaborating investigators from other departments and Brown University.
Coordinates daily non-clinical activities of the program and serves as key contact for IRB and regulatory aspects
Maintains thorough knowledge of and adheres to all requirements and guidelines of the Hassenfeld Study and associated research
Serves as a resource to physicians and staff, accurately answering questions regarding studies and ethical conduct of human subjects research
Collaborates with team members to identify routine activities/processes and influencing factors, and develops effective procedures to accomplish and monitor study goals
Implements new procedures, providing instruction when necessary, and monitors compliance through observation and analysis of reports
Serves as key contact regarding IRB and other regulatory issues
2. Coordinates all IRB submissions and maintains approvals
Creates, edits, and revises study-related materials such as protocols, informed consent forms, patient recruitment materials, patient hand-outs, etc.
Submits IRB applications in a timely manner for new studies, continuing review of ongoing research, and amendments in accordance with federal and local regulations
Prepares and submits various reports to the IRB, including notification of study team changes, unanticipated problems, and protocol violations according to the required timeline
Promptly responds to questions and pre-review comments from IRB staff and the board
3. Facilitates clear communication with study team and collaborators
Submits and discusses IRB-related agenda items during team meetings
Identifies action items and monitors problems toward completion
Disseminates IRB decisions and provides updates regarding pending submissions
Promptly notifies team of regulatory issues impacting subject safety, recruitment efforts, research procedures, etc.
4. Prepares and maintains regulatory files
Establishes organizational system for filing and storage of essential documents and regulatory correspondence
Ensures study files are regularly updated and accessible to team members
5. Develops and maintains network of contacts to effectively coordinate program
6. Preserves and protects confidentiality of hospital information
Discusses confidential information concerning program and its participants only when related to job responsibilities
Treats records, files, and other confidential documents with the utmost security
7. Performs other job-related duties as required
Maintains and enhances technical skills, demonstrating willingness to learn new software programs and applications
Participates in educational programs and keeps abreast of current trends in related fields
Maintains current knowledge of hospital policies, procedures and goals which may impact department programs
Helps with other activities as needed
Bachelor's degree with three years' experience in research, preferably in an academic/medical research environment, or equivalent combination of education and practical experience. Must have IRB experience and familiarity with IRBnet is highly desirable. Must have working knowledge of ICH Guidelines, U.S. Code of Federal REgulations, and ethical principles that guide clinical research. Must possess excellent organizational, interpersonal, and communication skills.
Manual dexterity and mobility required. While performing the major responsibilites of this positionl, the incumbnet must be able to regularly sit, stand or walk, and occasionally reach for prolonged periods of time. Must be able to lift, push, move and/or carry supplies or equipment up to 25 pounds, and occasionally be able to bend, stoop, crouch, or kneel.
Internal Number: 960-9674
About Women & Infants Hospital of Rhode Island
Women & Infants Hospital of Rhode Island, a Care New England hospital, is one of the nation’s leading specialty hospitals for women and newborns. The major teaching affiliate of The Warren Alpert Medical School of Brown University for activities unique to women and newborns, Women & Infants is the 9th largest stand-alone obstetrical service in the country with approximately 8,500 deliveries per year.
A Designated Baby-Friendly USA Hospital, U.S.News & World Report 2014-15 Best Children’s Hospital in Neonatology and a 2014 Leapfrog Top Hospital, in 2009, Women & Infants opened what was at the time the country’s largest, single-family room neonatal intensive care unit.
New England’s premier hospital for women and newborns, Women & Infants and Brown offer fellowship programs in gynecologic oncology, maternal-fetal medicine, urogynecology and reconstructive pelvic surgery, women's mental health, neonatal-perinatal medicine, pediatric and perinatal pathology, gynecologic pathology and cytopathology, breast disease, obstetric medicine and reproductive endocrinology and infertility.
Women & Infants has been designated as a Breast Imaging Center of Excellence from the American Col...lege of Radiology; a Center of Excellence in Minimally Invasive Gynecology; a Center of Biomedical Research Excellence for Perinatal Biology by the National Institutes of Health; and a Neonatal Resource Services Center of Excellence. It is one of the largest and most prestigious research facilities in high risk and normal obstetrics, gynecology and newborn pediatrics in the nation, and is a member of the NRG Oncology, the Maternal-Fetal Medicine Units Network, the Neonatal Research Network, and the Pelvic Floor Disorders Network.