Job Description
Required Qualifications (as evidenced by an attached resume):
Bachelor's Degree (foreign equivalent or higher). Two (2) years of full-time clinical research experience. Experience working with study participants. Experience with data analysis, data collection and electronic database entry.
Preferred Qualifications: Certifications for clinical research (i.e Certified Human Research Biomedical Course, research HIPPA training). Experience with hospital electronic medical record review (i.e Cerner Powerchart). Experience working with an IRB (Investigational Review Board) for research protocol submissions, amendments and reviews. Experience with research informed consent process for subject enrollment into trials. Experience in Microsoft Office.
Brief Description of Duties: Be responsible for management of clinical trials conducted at Stony Brook University, Neurosurgical Department. Will conduct screening and recruitment of Neurosurgical patients, obtain study informed consent, data collection, and quality assurance. Will assist with study-related administrative tasks, such as preparing IRB submissions, interim progress reports, updating study databases and study-related correspondence. Will work closely with the sponsors and site physicians for study management. Demonstrates basic computer proficiency. Meets clinical competency requirements. Develops and maintains open dialogue with patient and key personnel to communicate schedule and protocol changes to assure compliance to research project.
Duties: - Recruit, screen, consent and assist with schedule of research patients for Neurosurgery clinical research trials; collect and submit clinical trial patient data, coordinate patient appointments.
- Maintain collected data in an electronic database.
- Maintain study protocol documents and IRB compliance.
- Perform various administrative duties; maintenance of clinical research study supplies and drug/device accountability.
- Educate families as well as clinical staff on the research protocol and investigative study drugs/devices.
- Coordinate patient appointments and assessments as per study protocols.
- Demonstrate proficiency with hospital EMR, basic computer skills.
- Coordinate various research trials and ensure compliance with federal guidelines.
- Interact and correspond with various internal and external constituents including sponsors, cooperative groups, Institutional Review Board and regulatory agencies.
- May assist the principal investigator with grant submissions and renewals.
- Attend conferences and research meetings.
- Assure timely communication of regulatory documents to the IRB. Report Serious Adverse Events as they occur and assists with the completion of FDA and Sponsor forms in accordance with GCP timelines. Oversee research equipment and study supplies.
- Maintains knowledge and assure adherence to the Code of Federal regulations related to clinical research.
- Maintain current certification in Human Subjects Research as required .
- Facilitate the preparation of conference abstracts, oral presentations, and poster presentations, and participate in the development of manuscripts for publication .
- Partner with departmental IT resources in the development of databases; data coding manuals and data entry guidelines .
- Ensure that adverse events and protocol deviations are submitted to the IRB .
- May provide research support for clinical trial patient enrollment for acute trials after business hours, on occasion as needed.
- Other duties as assigned.
Special Notes:
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.
For this position, we are unable to sponsor candidates for work visas.
Resume/CV and cover letter should be included with the online application.
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws. If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at (631) 632-6280 or visit OEA.
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SUNY Research Foundation: A Great Place to Work. The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Job Tags
Full time, Interim role, Work visa,