Florida Orthopaedic Institute is offering a one-year research fellowship in orthopaedic research with a focus on hand and upper extremity. The fellowship will begin May/June 2023. The primary function of the research fellow is to coordinate the conduct of orthopaedic clinical research protocols with an emphasis on creation and maintenance of IRB, screening/enrolling patients and maintaining follow-up outcomes for open studies and databases, data collection and analysis, and manuscript preparation and submission.

Application Deadline: April  15, 2023

Where: Florida Orthopaedic Institute, Tampa, Fl

Start: Approximately June 1, 2021- negotiable

Duration: 1 year full-time, paid position

Job Description: Primary function of position 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 is responsible for data collection and analysis along with manuscript preparation and submission. On a daily basis I am going to various FOI clinic locations including Telecom, Citrus park, South Tampa, and Brandon, interacting with patients, study sponsors, principal investigators, sub investigators, clinical staff, administrative staff, and IRB staff. I attend weekly hand conferences Monday and Thursday mornings, as well as Grand Rounds on Friday mornings, and monthly journal clubs.

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 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)

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
• 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
• Attend weekly Trauma Hand Conference
• Assist Fellows with Research Projects, data collection, literature searches, case studies.

 Goals: My goal for this year is to increase the productivity of research for the hand and upper extremity department, organize all research projects and improve the quality of research studies. I am completing this research fellowship year to improve my research skills/orthopaedic knowledge, gain connections/networking in the field of orthoapaedics, and gain mentorship to further my career of becoming an orthopaedic surgeon. I am applying for a residency position in orthopaedic surgery this year and ideally would like to match at USF. (Nino Coutelle- present fellow)

Please Submit Cover letter and CV to Nino Coutelle at This email address is being protected from spambots. You need JavaScript enabled to view it..