Sr. Clinical Research Associate

Axogen•Tampa, FL

2d•$92,293 - $115,367•Onsite

About The Position

This Sr. CRA position will operate as the main point of contact for assigned sponsored study sites and investigator-initiated studies. The Sr. CRA will perform investigator set up and 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 Sr. CRA will assist with training and onboarding activities for new CRAs. The Sr. CRA will coordinate with Clinical Research Managers to establish monitoring plans and ensure assigned CRAs execute according to the plan. They assume accountability for assigned study site performance, providing high quality data, according to established timelines.

Requirements

Must have a bachelor’s degree in a scientific discipline at a minimum.
Four years previous clinical research experience in Phase III –IV studies.
Strong knowledge of anatomy and physiology
Experience with assisting in protocol design, study document creation, and database design/maintenance
Capable of working on clinical monitoring issues of moderate scope
Demonstrates the ability to build relationships with clinical sites/investigators to ensure compliance with protocols and regulatory requirements
Ability to read and critically interpret relevant literature. Serve as a resource for clinical knowledge.
Oral and written communication skills are essential
Exercises judgment on routine clinical procedures and practices to determine appropriate action
Strong interpersonal skills, exceptional organizational and time-management skills
Ability to work independently and collaboratively in a team environment
Ability to manage and coordinate CRA activities as needed for assigned study projects
Ability to quickly adapt to changes in departmental priorities and goals to meet company strategies and directives
Knowledge of GCP/IHC regulatory requirements
Must be willing to travel (50% of time)
Consistently anticipates and finds ways to overcome obstacles to achieving the goals
Holds himself/herself accountable for taking tasks all the way to completion
Can clearly communicate important company goals and what he/she needs to do in order to accomplish them

Nice To Haves

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

Responsibilities

Assist with development and implementation of protocol design, study training documents, study documents, and plan management for sponsored and investigator initiated studies.
Conduct Site Qualification, initiation visits, on-site monitoring visits, co-monitoring visits, and site closure visits of all phases of clinical studies.
Interfaces with clinical sites/investigators on-site and through off-site administrative site management to ensure compliance with protocols and regulatory compliance
Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions
Prepares and/or tracks required documentation for clinical sites (contracts, budgets, IRB documentation)
Conduct orientation and onboarding and training activities for new CRAs.
Coordinate with Clinical Research Managers to establish monitoring plans and ensure assigned CRAs execute according to the plan.
Assumes accountability for assigned study site performance, providing high quality data, according to established timelines.
Assists Clinical Operations staff and study site staff to quickly identify, effectively resolve issues, and implement corrective and preventive actions.
Assists with the development and maintenance of study databases
Review, retrieve, and report study data as the requirements dictate or as appropriate
Prepares reports of study progress to upper management