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Job Description:
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters a work-life balance and 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 the leading company revolutionizing the science of nerve repair. We are passionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.
Contribute to positively impacting lives while working for a company that respects, recognizes, and values all team members!
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
- Flexible working hours
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
Axogen is hiring for a Clinical Research Associate in Tampa, FL!
Job Summary of the Clinical Research Associate
The Clinical Research Associate will function as the main point of contact for assigned sponsored and investigatorinitiated 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.
Requirements of the Clinical Research Associate
- Bachelor's degree required in a scientific discipline
- At least 2 years of Clinical Research Associate experience
- Independent judgment, critical-thinking skills and discretionary decision-making skills.
- Ability to multi-task and prioritize autonomously.
- Excellent written & oral communications skills.
- Must be willing to travel (50% of the time)
Responsibilities of the Clinical Research Associate
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 subject recruitment and smooth implementation of studies by leading, guiding and motivating site personnel to complete study goals.
- 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.
- Assist with 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.
Location
111 West Oak Ave., Tampa, FL 33602
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Benefits/Compensation
This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 2 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
Salary Range
$72,142-$90,177 USD
Axogen is on a hybrid work schedule for some of our positions based out of our headquarters in Florida, with 3 days in office and 2 days remote. The hybrid work schedule does not include sales or facilities in Ohio or Texas.
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.
If you know someone who would be a great candidate for this position, or any others, just copy and send this link! https://grnh.se/cc84962d2us
