Clinical Research Associate II Position Available In Hillsborough, Florida

Clinical Research Associate II Axogen – 2.7 Tampa, FL Job Details $81,737 – $102,171 a year 12 hours ago Benefits Employee stock purchase plan Paid holidays Tuition reimbursement 401(k) matching Referral program Qualifications Clinical research Biomedical Engineering Mid-level Bachelor’s degree Trauma medicine Clinical trials Plastic surgery Associate’s degree Communication skills Full Job Description Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one! Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. Why you’ll love working at

Axogen:

Friendly, open, and fun team culture that values unique perspectives Company-wide dedication to profoundly impacting patients’ lives Comprehensive, high-quality benefits package effective on date of hire Educational assistance available for all employees Matching 401(k) retirement plan Paid holidays, including floating holidays, to be used at your discretion Employee Stock Purchase Plan Referral incentive program Axogen Mission and Business Purpose Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care. Job Summary of the Clinical Research Associate II The Clinical Research Associate will function as the main point of contact for assigned sponsored and investigator- initiated studies. The CRA II 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. The CRA II will also act as a resource for new CRAs in setting a high standard for site management, data review, and SOP compliance. They will also assist, as needed, as a back-up resource for other clinical projects within Clinical Operations and assume accountability for assigned study site performance and begin to support the CRM on project-level tasks. Requirements of the Clinical Research Associate II Bachelor’s degree required in a scientific or biomedical engineering discipline At least 3 years of Clinical Research Associate Research experience in device, trauma, orthopedic, or reconstructive surgery is a preferred Independent judgment, critical-thinking skills and discretionary decision-making Ability to multi-task and prioritize Excellent written & oral communication and presentation skills Must be willing to travel (50% of the time) Responsibilities of the Clinical Research Associate II The specific duties of the Clinical Research Associate II 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. Conducts 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). Performs CRA duties for more than one protocol or serves on more than one project Serves as a back-up resource for other clinical studies in Clinical 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 correctiveactions. Ensures 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 Ensures timely subject recruitment and smooth implementation of studies by leading, guiding and motivating site personnel to complete study goals. Ensures 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 Assists with the development and maintenance of study Assists with preparation and execution of Investigator meetings, including participation in presentation of study Assists, as needed, with orientation and onboarding and training of new CRAs Autonomously manages assigned sites and independently offers solutions to issues Assists in identifying and resolving solutions to project-level issues Manages documentation issues with CROs and/or study Complies with all company policies, procedures, and Other projects and duties as required/assigned. Location 111 West Oak Ave., Tampa, FL 33602 #LI-AC1 Benefits/Compensation Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.