Associate Scientist

University of Miami•Miami, FL

12d•Onsite

About The Position

The University of Miami/UHealth Department of OBGYN has an exciting opportunity for a full-time Associate Scientist, SOM to work in Miami, FL. The Associate Scientist, SOM (A) supports the University’s research goals and objectives by performing laboratory experiments in his/her areas of interest, expertise, or assignment. Moreover, the incumbent performs various analytical procedures involving method development and application development and synthesis. The Fetal Surgery Program is seeking Associate Scientist to advance the research portfolio. The ideal candidate will be highly motivated, knowledgeable, adaptable, and ready to thrive in a dynamic environment that may require a flexible work schedule. We are particularly looking for someone with high attention to detail, proven experience in managing regulatory documentation and submissions to entities such as the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). This role is essential for ensuring compliance and supporting the integrity of our clinical research efforts.

Requirements

Ph.D., M.D. or other doctoral level degree in relevant field
Minimum 5 years of relevant experience
Skill in collecting, organizing, and analyzing data.
Ability to recognize, analyze, and solve a variety of problems.
Ability to exercise sound judgment in making critical decisions.

Nice To Haves

FDA experience highly desired/preferred

Responsibilities

Contributes to basic and applied research activities including authorship of scientific publications, technical and agency reports, and patent preparations.
Publishes in refereed journals in collaboration with department leadership or independently.
Supervises research employees and non-exempt staff.
Writes extramural proposals with approval of senior managing staff.
Creates and conducts experiments and analyzes results.
Works with other researchers to use and develop end products.
Provides ready access to all experimental data for the faculty researchers, supervisors, and other relevant staff.
Requests or acquires equipment and supplies for assigned project(s).
Applies for grants to continue research and prepares materials for submission to granting agencies and foundations.
Adheres to University and unit-level policies and procedures and safeguards University assets.
Complete regulatory IRB submissions, continuing reports, and modifications of protocols, including maintaining delegation of authority logs, deviation logs, adverse event logs for all studies. This requires a high level of accuracy and attention to detail.
Ensures screening, recruitment, including informed consent of participants per protocol guidelines with high level of accuracy.
Completes scheduling and contacting study participants for appointments as needed.
Design and build databases for data collection, data entry and completing standard operating procedures for quality assurance reviews of data as needed.
Ensures data integrity and consistency in computer databases and written records.
Design and implement methods for study monitoring and tracking of study visits by protocol guidelines.
Ensure all essential documentation including maintenance of study binders, shadow records, and record reviews for study specific data collection per protocol.
Develops, verifies, and implements procedures to accomplish research goals.
Implements research protocol and monitor participant adherence to protocol.
Recruit participants for research studies following the specified recruitment guidelines.
Conduct an informed consent interview in various settings with potential participants.
Completes all study required forms according to study protocol.
Schedule return for follow-up data collection according to protocol directions.
Responsible for verifying accurate study and research data, documentation and quality control, and abstracts medical record information as needed by study protocol.
Responsible for regulatory oversight, to include preparing and submitting initial study requests, annual reviews and modifications to the Institutional Review Board (IRB), while maintaining consent forms and sponsor correspondences, and notifying the IRB of protocol amendments, safety reports and serious adverse events, etc. in compliance with applicable regulations.
Establishes and maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants.
Maintains drug accountability records for study drugs or devices, as applicable.
Determines data to be collected and develops forms for collecting/summarizing data.
Completes corrections/queries required at audits/monitor visits and acts to correct deviations as needed.
Updates appropriate agencies (such as sponsors, IRB, etc.) regarding status of research project.
Provides in-service education to staff and patients/participants about research protocols.
Maintains database of department, providing research training and support, ensuring CITI certification and relevant training are up to date.
Attends University of Miami research related education and training as appropriate.
Collaborate with students, residents, faculty and other stakeholders to conduct research effectively.
Support knowledge dissemination by preparing presentations for conferences and other forums as applicable and prepare manuscripts for submission to peer reviewed publications.