POSITION FILLED

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 2021. 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.

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). In addition, the research fellow is encouraged to attend weekly conferences and grand rounds as well as monthly journal clubs. 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 and help fellow strengthen their application for an orthopedic surgery residency position.

Application Deadline: March 31, 2021

Where: Florida Orthopaedic Institute, Tampa, Fl

Start: Approximately June 1, 2021- 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 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
• Participate in Limb Loss Clinic (one afternoon a month) collecting PROM’s.
• Maintain database for Limb Loss Clinic
• Attend weekly Trauma Hand Conference
• Assist Fellows with Research Projects, data collection, literature searches, case studies.

Interested Applicants Should Submit the following: 

Cover Letter

CV 

Submit to Meera Gill at This email address is being protected from spambots. You need JavaScript enabled to view it.