Clinical Research Associate

AxoGen Overview
AxoGen (AXGN) is a global leader in innovative surgical solutions for peripheral nerve injuries. AxoGen is focused on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Damage to a peripheral nerve can result in the loss of muscle or organ function, the loss of sensory feeling or the initiation of pain. Injuries to peripheral nerves can significantly impact the patient's quality of life.
AxoGen's portfolio of products includes Avance? Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard? Nerve Connector, a porcine submucosa extracellular matrix ("ECM") coaptation aid for tensionless repair of severed nerves, AxoGuard? Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments and Avive? Soft Tissue Membrane, a minimally processed human umbilical cord membrane that may be used as a soft tissue covering to reduce inflammation and scar tissue formation. Along with these core surgical products, AxoGen also offers AxoTouch? Two-Point Discriminator and AcroValTM Neurosensory & Motor Testing System. These evaluation and measurement tools assist healthcare professionals in detecting changes in sensation, assessing return of sensory, grip and pinch function, evaluating effective treatment interventions, and providing feedback to patients on nerve function. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom and several European and international countries.
AxoGen maintains its corporate offices in Alachua, Florida.
AxoGen provides a great work environment that includes a fast-paced innovative team with a strong commitment to restoring quality of life to patients with nerve injuries.
Job Summary
The Clinical Research Associate will function as the main point of contact for assigned sponsored and investigator initiated studies. The CRA will perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs) including site GCP compliance, trouble shoot issues and facilitate resolution and monitor safety at the site. The position will also conduct site qualification visits as assigned, site initiation visits and site training, routine monitoring visits and site close-out visits.
Primary Responsibilities: The specific duties of the Clinical Research Associate include but are not limited to:
Interfaces with clinical sites/investigators on and off site as part of administrative site management to ensure compliance with protocols and regulatory compliance
Conduct site qualification, initiation visits, on-site monitoring visits, co-monitoring visits and site closure visits of all phases of clinical trials. Assist with the resolution of data queries. Write site visit reports or reviewing monitoring reports provided by Contract Research Organizations (CRO)
Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by providing: site training, guidance of investigators and site study team, and follow-up of corrective actions
Ensure International Conference on Harmonization and Good Clinical Practice procedures are followed in all study aspects
Reviews study data for completeness, accuracy and consistency with study protocol
Ensure timely, accurate collection of all adverse events, adverse reactions and complaint reports and implement follow-up actions
Prepares reports of study progress to upper management
Prepares and/or tracks required documentation for clinical sites (contracts, budgets, IRB documentation)
Assists with information gathering, literature searches, data analysis, report generation and creation of presentations
Assists with the development and maintenance of study databases and preparation and execution of Investigator meetings
Manage documentation issues with CROs and/or study sites
Comply with all company policies, procedures and SOPs
Other projects and duties as required/assigned
We are seeking candidates who are AxoGenic, which means:
Respect is the foundation for communication and action.
Patient safety is our first priority.
In being effective stewards of the gift of human tissue.
In creating and maintaining a company culture that encourages and rewards honesty, openness, passionate debate - and fun!
Individual ownership and empowerment lead to superior team results.
The organization, its members and partners must consistently achieve agreed upon results with flexibility and mutual support.
Speed is critical!

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