Research Program Coordinator I-Regulatory Affairs-Neurosurgery
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Job Location:
New York City, NY - USA
Monthly Salary:
USD 58661 - 81675
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
The Research Program Coordinator I develops and/or participates in study protocols designs management and statistical plans analyzes data and prepares final reports from study. This position is responsible for human subjects or laboratory research depending on department and type of study assigned.
Responsibilities
- Provides assistance and consultation on basic research or clinical trials methodologies and statistical analysis issues.
- Participates in the primary analysis of evaluation datasets.
- Designs and implements research projects focusing on health and interventions and their associated health outcomes.
- Assists evaluation staff in project design appropriate procedures and conduct and coordination by establishing sample size requirements calculating issues associated with various evaluation design options and consulting on appropriate statistical analysis for proposed evaluations.
- Documents and records observations on progress of research investigations and data per regulatory requirements and MSMC protocols.
- Supervises subordinate personnel and offers guidance on research methods and techniques.
- Provides assistance to the Principle Investigator or Research Manager on grant applications.
- Assists in the development of budgets for research projects. Completes grant applications and proposals by developing pilot studies and generating pre-clinical data.
- Completes all Institutional Review Board (IRB) or IACUC and other regulatory applications and renewals.
- Develops consent forms screens and enrolls patients follows patients through course of study collects and analyze data. (Clinical Research only)
- Develops policies and procedures within area of responsibility. Writes and amends protocols as necessary.
- Participates in conferences meetings and seminars concerning research and surveillance projects.
- Collaborates with fellows on research projects and papers to be published.
- Maintains and submits the regulatory requirements for the FREEDOM Clinical Coordinating Center at Mount Sinai Medical Center. (those performing Clinical Research only)
- Performs other related duties.
Qualifications
- Masters degree in Natural Sciences OR Bachelors degree in Natural Sciences plus 5 years of progressive research experience with some experience in research administration preferred
- 4 years of research experience (5 years if no Masters degree) in data management and study coordination in healthcare or basic research.
Non-Bargaining Unit 842 - Neurosurgery - ISM Icahn School of Medicine
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Strength through Unity and Inclusion The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai’s unparalleled ... View more
