Clinical Research Associate II

Axogen • Tampa, FL

4d • Onsite

About The Position

The Clinical Research Associate II 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

• Bachelor’s degree required in a scientific or biomedical engineering discipline
• At least 3 years of Clinical Research Associate experience.
• Research experience in device, trauma, orthopedic, or reconstructive surgery is a preferred
• Independent judgment, critical-thinking skills 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 Contract Research Organizations (CROs).
• 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.

Benefits

• Health
• Dental
• Vision
• Matching 401K
• 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
• Employee Stock Purchase Plan
• Disability Insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level