Clinical Research Associate II (Extremities Specialty)

Axogen develops solutions to restore peripheral nerve function and improve patients’ quality of life. The Clinical Research Associate II manages assigned clinical study sites, monitors regulatory and protocol compliance, and supports study execution and other clinical operations projects.

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 Contract Research Organizations (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 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

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 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

Preferred

Research experience in device, trauma, orthopedic, or reconstructive surgery is a preferred

Medical Device Research

Trauma Surgery Research

Orthopedic Surgery Research

Reconstructive Surgery Research

Benefits

Annual bonus

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

Health insurance

Dental insurance

Vision insurance

Paid Time Off

9 Paid Holidays + 3 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

Disability Insurance

Company

Peripheral nerve regeneration and repair technologies

Alachua, Florida, USA

http://www.axogeninc.com/

Founded in 2002

201-500 employees

Qualifications

Bachelor's degree required in a scientific or biomedical engineering discipline

At least 3 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 communication and presentation skills

Research experience in device, trauma, orthopedic, or reconstructive surgery is a preferred

At least 3 years of Clinical Research Associate experience.

Required skills

Clinical Research, Clinical Practice (GCP), International Conference on Harmonisation (ICH), Clinical Trial Monitoring, Clinical Site Management

Experience

3+ years