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Axogenis the leadingcompany revolutionizing thescience of nerve repair.We arepassionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.
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Why you'll love working atAxogen:
- Friendly, open,andfunteam culturethat values uniqueperspectives
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- Comprehensive, high-quality benefitspackage effective on date of hire
- Educationalassistanceavailable for all employees
- Matching 401(k)retirementplan
- Flexible working hours
- Paid holidays,including floating holidays,to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
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Axogen is hiring for aClinical Research Associate in Tampa or Alachua, FL!
Job Summary of the Clinical Research Associate
The Clinical Research Associate functions as the main point of contact between the sponsor and the clinical research site in Axogen sponsored and Investigator-Initiated clinical studies. The CRA monitors Axogen sponsored clinical studies to ensure compliance with all applicable regulations, Good Clinical Practices, and standard operating procedures (SOPs). Additionally, the CRA is responsible for effectively managing clinical research sites to drive their performance throughout the clinical study life-cycle from identification, qualification, and activation through study closure.
Requirements of the Clinical Research Associate
- Bachelor's degree in a medical or scientific discipline or a commensurate combination of training and experience;
- At least 2 years of experience as a Clinical Research Associate;
- Strong critical thinking and discretionary decision-making skills;
- Strong organizational and time-management skills;
- Ability to multi-task and prioritize autonomously;
- Excellent written & oral communication skills;
- Ability and willingness to travel (up to 50% of the time)
Responsibilities of the Clinical Research Associate
- Interfacing with clinical investigators and study personnel to drive performance and ensure compliance with the study protocol, applicable regulations, and Good Clinical Practices;
- Identifying qualified clinical research investigators to participate in Axogen sponsored clinical studies;
- Conducting on-site monitoring activities through site qualification, site initiation, routine monitoring, and study close-out visits;
- Performing remote monitoring activities to drive site performance and to ensure that study data are complete, accurate, and verifiable;
- Preparing detailed and compliant monitoring reports and related documentation demonstrating that Axogen achieves its monitoring obligations;
- Assisting in the development of clinical study documents such as protocols, monitoring plans, study reports, presentations, and related materials.
- Ensuring compliance with the investigational plan, study protocol and applicable regulatory requirements, and Good Clinical Practices (GCP) by providing training, guidance, and support to investigators and site personnel through the study;
- Improving site performance and compliance by creating and managing effective corrective actions plans;
- Reviewing study data for completeness, accuracy and consistency with study protocol;
- Ensuring timely recruitment and smooth operational performance by leading, guiding and motivating site personnel to achieve study goals;
- Ensuring timely, accurate reporting of all adverse events, adverse reactions, and complaint reports;
- Preparing reports of study progress for Axogen's leadership team;
- Prepares and/or tracks essential study documents (contracts, budgets, IRB documentation);
- Assists with information gathering, literature searches, data analysis, report generation, and creation of presentations;
- Assists with preparation and execution of Investigator meetings;
- Other projects and duties as required/assigned.
If you know someone who would be a great candidate for thisposition, justcopy and send this link!
111 West Oak Ave., Tampa, FL 33602
13631 Progress Blvd., Alachua, FL 32615
U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Axogen are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.