Stony Brook University Clinical Research Associate II in Stony Brook, New York
Clinical Research Associate II
Required Qualifications : (As evidenced by an attached resume)
Bachelors degree (equivalent) or higher in Nursing. Licensed to practice as a RN in NYS. Two years of experience managing clinical research trials. Ability to use an electronic medical record.
Previous experience as a RN leading or participating in industry sponsored, site-initiated or NIH clinical research trials. Knowledge of the IRB and regulatory processes. Prior experience entering data into electronic data capture (EDCs). Proficiency with MS Office products (primarily Word and Excel). Certification as a Certified Clinical Research Coordinator (CCRC). Proficiency with the EMR, Cerner.
Brief Description of Duties:
The Clinical Research Associate II will assist in the review of clinical research studies and participate in all facets of research protocol performance by working with administrative research associates and investigators. The incumbent will possess excellent interpersonal and team building skills.
Assess eligiblity of patients to become study participants; recruit suitable patients as study participants and obtain informed consent. May include various screening processes including chart review, screening patients admitted to the hospital or presenting for procedures. Personally discuss the details involved, etc. with all enrolled patients. Answer patient questions regarding procedures and protocols as required.
Ensure all required tests and exams are obtained and documented on CRFs and source documents as per study protocol. Process blood and laboratory specimens as needed. This includes ensuring that all necessary procedures are followed and at the time required. Monitor patient safety criteria to ensure patients enrolled have test results within the identified parameters.
Prepare material for data presentations of study progress for funding agencies.
Ensure required patient follow-up visits are scheduled and completed per protocol.
Responsible for data collection for study analysis as well as maintaining all records as required by study protocols and maintaining patients' medical records/data during the study period.
Submit protocols, amendments, notices and terminations to the Institutional Review Board (IRB) for review and approval. Revise protocol and consent forms as needed to comply with Federal, State and IRB guidelines. Responsible for reporting all adverse events. Must also review the contract between the sponsor and University Hospital. Assist with the analysis of the patient data ensuring that all required components are accurately entered in the various databases.
Patient/staff education: educate patients, families and cardiology staff on the research process and available protocols.
Other duties as assigned.
The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding.FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.
Stony Brook University is 100% tobacco-free as of January 1, 2016. See our policy and learn more atstonybrook.edu/tobaccofree.
About Stony Brook:
Long Island’s premier academic medical center, Stony Brook Medicine represents Stony Brook University’s entire medical enterprise and integrates all of Stony Brook’s health-related initiatives: education, research and patient care. It encompasses Stony Brook University Hospital, Stony Brook Children’s Hospital, the six Health Sciences schools — Dental Medicine, Health Technology and Management, Pharmaceutical Sciences, Medicine, Nursing and Social Welfare — as well as the major centers and institutes, programs and more than 50 community-based healthcare settings throughout Suffolk County. With 603 beds, Stony Brook University Hospital serves as Suffolk County’s only tertiary care center and Regional Trauma Center. Stony Brook Children’s, with more than 180 pediatric specialists in 30 specialties, offers the most advanced pediatric specialty care in the region.
Equal Opportunity Employer, females, minorities, disabled, veterans.
If you need a disability related accommodation, please call the University Human Resource Services Department at (631) 632- 6161 or the University Hospital Human Resources Department at (631) 444-4700. In accordance with the Title II Crime Awareness and Security Act, a copy of our crime statistics is available upon request by calling (631) 632- 6350. It can also be viewed on line at the University Police website at http://www.stonybrook.edu/police .
Job Field: Research Professional / Technical
Primary Location: US-NY-Stony Brook
Official Job Title: Clinical Research Associate II
Department/Hiring Area: Medicine - Cardio
The Research Foundation for The State University of New York at Stony Brook
Pass Days: Day Shift
Posting Start Date: Aug 7, 2018
Posting End Date: Aug 21, 2018, 10:59:00 PM
Salary: $68,000-$80,000 / Annual @ 1.0 FTE CWE
Salary Grade: E99
Req ID: 1801856