Breast Specialty CRA II — Drive Clinical Impact

Axogen, Inc.; Tampa (FL); On-site; USD 84,000 - 105,000; Full time

Benefits offered by this job

Health

Dental

Vision

Matching 401K

Paid Time Off

9 Paid Holidays + 3 Floating Holidays

Dependent Care Flexible Spending Acts

Medical Flexible Spending Accounts

Tuition Reimbursement

Paid Parental Leave

Paid Caregiver Leave

Basic Life Insurance

Supplemental Life Insurance

Employee Stock Purchase Plan

Disability Insurance

Job summary

Axogen, Inc. in Tampa, FL is seeking a Clinical Research Associate II to oversee assigned sponsored and investigator-initiated studies. The CRA II will manage site activities in line with regulatory guidelines, SOPs, and GCP, troubleshoot issues, monitor safety, and coordinate site visits.

You will train new CRAs, support project-level tasks, and ensure timely data collection and reporting. Travel up to 50% is expected, with a focus on site performance and compliance across multiple protocols.

Qualifications

• Bachelor's degree in a scientific or biomedical engineering discipline.
• At least 3 years of Clinical Research Associate experience.
• Experience in device, trauma, orthopedic, or reconstructive surgery preferred.
• Independent judgment, critical-thinking and discretionary decision-making skills.
• Ability to multi-task and prioritize autonomously.
• Excellent written & oral communication and presentation skills.
• Must be willing to travel (50% of the time).

Responsibilities

• 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 CRO
• Performs CRA duties for more than one protocol or serves on more than one project team
• Serves as a back-up resource for other clinical studies in Clinical Operations
• 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
• Ensures ICH, Good Clinical Practice procedures are followed in all study aspects
• Reviews study data for completeness, accuracy and consistency with study protocol
• Ensures timely subject recruitment and smooth implementation of studies by leading, guiding and motivating site personnel
• 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 presentations
• Assists with the development and maintenance of study databases
• Assists with preparation and execution of Investigator meetings, including participation in presentation of study updates
• 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 sites
• Complies with all company policies, procedures, and SOPs
• Other projects and duties as required/assigned

Skills

Regulatory compliance

GCP adherence

Site monitoring

Multi-tasking

Excellent communication

Travel 50%

Education

Bachelor's degree in scientific or biomedical engineering

Job description

Axogen, Inc. in Tampa, FL is seeking a Clinical Research Associate II to oversee assigned sponsored and investigator-initiated studies. The CRA II will manage site activities in line with regulatory guidelines, SOPs, and GCP, troubleshoot issues, monitor safety, and coordinate site visits.

You will train new CRAs, support project-level tasks, and ensure timely data collection and reporting. Travel up to 50% is expected, with a focus on site performance and compliance across multiple protocols.