Sr. Clinical Research Associate

Axogen•Tampa, FL

About The Position

The Sr. Clinical Research Associate serves as the primary contact for assigned sponsored study sites and investigator-initiated studies. The role conducts investigator setup and site management in accordance with applicable regulatory guidelines and standard operating procedures, supports site GCP compliance, addresses issues and facilitates resolution, and monitors site safety. The Sr. CRA also supports the training and onboarding of new CRAs and coordinates with Clinical Research Managers on monitoring plans and their execution. The position is accountable for assigned site performance, high-quality data, and established timelines. The role supports the design and implementation of clinical study protocols, training materials, study documents, and management plans; conducts site qualification, initiation, monitoring, co-monitoring, and closure visits; and works with clinical sites and investigators to maintain protocol and regulatory compliance. It also tracks site documentation, supports study databases, reviews and reports study data, helps resolve issues and implement corrective and preventive actions, and reports study progress to upper management. Travel is required 50% of the time. The position is based at 111 West Oak Ave., Tampa, FL 33602.

Requirements

Bachelor’s degree in a scientific discipline at a minimum.
Four years of previous clinical research experience in Phase III–IV studies.
Strong knowledge of anatomy and physiology.
Experience assisting with protocol design, study-document creation, and database design or maintenance.
Ability to work on clinical monitoring issues of moderate scope.
Ability to build relationships with clinical sites and investigators to ensure compliance with protocols and regulatory requirements.
Ability to read and critically interpret relevant literature and serve as a resource for clinical knowledge.
Strong oral and written communication skills.
Ability to exercise judgment on routine clinical procedures and practices to determine appropriate action.
Strong interpersonal skills and 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 adapt quickly to changes in departmental priorities and goals.
Knowledge of GCP/IHC regulatory requirements.
Willingness to travel 50% of the time.
Consistently anticipates and finds ways to overcome obstacles to achieve goals.
Takes accountability for completing tasks.
Can clearly communicate important company goals and what is needed to accomplish them.

Nice To Haves

Research experience in device, trauma, orthopedic, or reconstructive surgery.

Responsibilities

Assist with developing and implementing protocol designs, study training documents, study documents, and management plans for sponsored and investigator-initiated studies.
Conduct site qualification, initiation, on-site monitoring, co-monitoring, and site closure visits for clinical studies of all phases.
Interface with clinical sites and investigators on-site and through off-site administrative site management to ensure protocol and regulatory compliance.
Train and guide investigators and study coordinators on protocol and regulatory requirements, and follow up on corrective actions.
Prepare or track required clinical-site documentation, including contracts, budgets, and IRB documentation.
Conduct orientation, onboarding, and training activities for new CRAs.
Coordinate with Clinical Research Managers to establish monitoring plans and ensure assigned CRAs execute them.
Take accountability for assigned study-site performance, high-quality data, and established timelines.
Help Clinical Operations and study-site staff identify and resolve issues and implement corrective and preventive actions.
Assist with the development and maintenance of study databases.
Review, retrieve, and report study data as required or appropriate.
Prepare study-progress reports for upper management.