Foundation for Orthopaedic Research & Education (FORE) is offering a one-year research fellowship in orthopaedic research with a focus on adult reconstruction. The fellowship will begin May/June 2023. 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. The research fellow will manage both sponsored studies and investigator-initiated studies that entail both prospective and retrospective study and data management. 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 required to participate in weekly research meetings with the Adult Reconstruction team and encouraged to attend weekly conferences (including, but not limited to Adult Reconstruction) 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. 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, 2023

Where: Foundation for Orthopaedic Research and Education, Tampa, Fl

Start: Approximately June 1, 2023- June 1, 2024 (dates are negotiable)

Duration: 1 year full-time, paid position

Coordinate all clinical research activities 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 will require driving between the various satellite offices of FOI
• Screen, recruit, and enroll patients/research participants
• Maintain study source documentation
• 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 SOPs and guidelines
• Must comply with federal, state, and sponsor policies
• Understanding of budget for study, invoicing sponsor for subject visits, monitoring visits, and IRB where applicable
• Act as liaison for research subject, investigator, IRB sponsor, and healthcare professionals.
• Document device/product accountability (as applicable)

Responsibilities/Opportunities

• Manage essential regulatory documents
• Register study on ClinicalTrials.gov (if not done by sponsor)
• Complete case report forms (paper and electronic data capture) and address queries in a timely manner
• 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
• Facilitate study close out activities
• Coordinate research/project team meetings (if applicable)
• Collect, process and ship laboratory specimens (as applicable)
• Schedule subject visits and procedures
• Retain records/archive documents after study close out
• Assist Fellows with Research Projects, data collection, literature searches, case studies.

Interested applicants should submit the following: https://app.smartsheet.com/b/form/65b68ffd44e64a829da51d50e53a81f8