Position Summary:
Research FellowshipFoundation for Orthopaedic Research and Education is offering a one-year research fellowship in orthopaedic research with Florida Orthopaedic Institute (FOI) attendings. The fellowship will begin May/June 2024. The primary function of the research fellow is to coordinate orthopaedic clinical research protocols involving idea creation, protocol formulation, IRB submission, screening/enrolling patients, and maintaining follow-up outcomes for open studies/databases. Additionally, the research fellow will be responsible for data collection and analysis along with manuscript preparation and submission. This position entails interaction with patients, study sponsors, principal investigators (PI), sub-investigators (Sub I), clinical staff, administrative staff, radiology, and institutional review boards (IRB). The research fellow is encouraged to attend weekly conferences (including, but not limited to Hand/UE, Spine, Adult Reconstruction, Shoulder and Elbow, Sports) and grand rounds (University of South Florida, Department of Orthopaedics), as well as monthly journal clubs put on by sponsor/affiliate organizations. Shadowing in the operating room is an option depending on fulfillment of research obligations and surgeon amenability. During this Fellowship there will be access to the Biomechanics laboratory and various opportunities to be involved with Biomechanical research. While optional, research fellows are encouraged to participate in Biomechanics research and gain hands-on experience, such as cadaveric dissection, participation in various instrumentation techniques, joint arthroplasty, suturing and more. This opportunity requires an extremely motivated individual with strong organization and communication skills. The goal of this year is to improve fellow’s research skills in an academic environment, build connections in the field, and strengthen their application for an orthopedic surgery residency position.
Application Deadline: March 31, 2024
Where: Florida Orthopaedic Institute, Tampa, Fl
Start: Approximately June 1, 2024- June 1, 2025 (dates are negotiable)
Duration: 1 year full-time, paid position
Coordinate all clinical research activities and biomechanics with moderate supervision: · Adhere to an IRB approved protocol· Participate in the informed consent process of study subjects· Support the safety of clinical research patients/research participants· Coordinate protocol related research procedures, study visits, and follow-up care§ This may require driving between the various satellite offices of FOI· Screen, recruit and enroll patients/research participants· Maintain study source documents· Report adverse events per protocols and monitor adverse events at each study visit for treatment or resolution.§ Accurate and timely reporting of serious adverse events to sponsor and IRB· Understand good clinical practice (GCP) and regulatory compliance· Educate subjects and family on protocol, study intervention, study device/drug (if applicable), etc.· Comply with FORE SOP’s and guidelines· Must comply with federal, state, and sponsor policies.· Understanding of budget for study, invoicing sponsor for subject visits, monitoring visits and IRB if applicable· Act as liaison for research subject, investigator, IRB sponsor and healthcare professionals.· Document device/product accountability (as applicable)· Cadaveric dissection· Monitor testing protocol and data collection· Assist with specimen storage, biohazard disposal and bioskills laboratory maintenance· Sample preparation & fixture set-up
Responsibilities/Opportunities· Manage essential regulatory documents· Register study on ClinicalTrial.gov (if not done by sponsor)· Complete case report forms (paper and electronic data capture) and address queries timely· Submit documents to regulatory authorities (IRB, FDA, etc) and/or review/monitoring boards (DSMB, CEC or independent safety officer)· Facilitate pre-study, site qualification, study initiation, and monitoring visits· Coordinate research/project team meetings (if applicable)· Attend weekly Conferences· Assist Clinical Fellows with Research Projects, data collection, literature searches, case studies.
Interested applicants should submit the following: · Cover letter· CV· USMLE Step Scores (all available)· COMLEX Scores (all available)Copy and paste link below into browser to submit application.
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