Field Clinical Specialist (Position Filled)
Job Title: Field Clinical Specialist
Reports to: Vice President, Clinical Affairs
Osteal Therapeutics, Inc. is a clinical-stage company developing a novel pipeline of drug/device combination therapies for the treatment of orthopedic infections and their consequences. Our lead investigational candidate, VT-X7 was granted Orphan Drug, FastTrack and Qualified Infectious Disease Product designations by the FDA and is currently in Phase 2 comparative trials for the treatment of Periprosthetic Joint Infection (PJI). With a robust pipeline of additional indications and therapeutic candidates, we anticipate rapid and sustained growth.
Osteal is looking for an experienced Field Clinical Specialist to support our clinical research centers in investigator training, prospective subject enrollment, surgical case coverage and follow-up as part of our current Phase 2 clinical program. Reporting to the VP, Clinical Affairs, the Field Clinical Specialist will be a critical member of the team, providing clinical procedure support and assistance to our clinical study sites on execution of our Apex clinical research program. This is an opportunity for an experienced orthopedic representative to join a growing organization that will help transform the lives of patients living with orthopedic infections.
Support multiple clinical study sites during enrollment, treatment, follow-up, and reporting results of clinical study subjects, including:
Intraoperative support regarding the use of all investigational products and compliance to the clinical study protocol;
Clinical research site training related to the clinical study and proposed therapeutic treatments, products used, and procedures
Maintain a professional relationship with each principal investigator, clinical study research coordinator, and hospital nursing and administrative staff to assure that all clinical study activities are performed easily and accurately, in compliance with all applicable laws and regulations.
Provide operational support to include inventory accountability and transfers, product utilization forecasts, reporting of clinical study enrollment and performance; response to clinical study related requests from the Company or its contract research organization; and supporting activities for scientific and educational meetings
Maintain regulatory compliance with applicable laws and regulations to include timely and accurate reporting of all product complaints; professional and accurate representation of Company products and their instructions for use; and control of investigational product to prevent unauthorized clinical use.
Bachelor’s degree with at least 8 years of relevant experience supporting orthopedic clinical cases
Experience working with clinical studies preferred, but not required
Self-starter with good written and oral communication skills
Ability to multi-task and prioritize tasks according to trial needs
Willingness and ability to travel within the U.S. regularly (up to 90%)