Clinical Research Coordinator-Burns

 Receives direction from the principal investigator, supervisor, or other staff involved in research protocol(s). Gives direction to and works cooperatively with other research staff. Collaborates with various departments within the institution. Works cooperatively with other investigators and personnel at all levels. Interacts with research participants, other research centers, and sponsoring companies to resolve problems and ensure efficient completion of research studies.

•   Coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the supervisor in compliance with regulatory laws and institutional guidelines 

•   Collaborates with the research team to assess the feasibility and management of research protocols 

•   Ensures implementation of research protocols after IRB/REC approval and provides information as appropriate for progress reports 

•   Screens, enrolls and recruits research participants 

•   Coordinates schedules and monitors research activities and subject participation 

•   Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately 

•   Manages, monitors, and reports research data to maintain quality and compliance. 

•   Provides education/training for others within the department 

•   Performs administrative and regulatory duties related to the study as appropriate. 

•   Protocol Development and Maintenance Activities  may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of Clinical trials unit, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board/Research Ethics Board (IRB/REC) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements.  

•   Accurately applies investigators’ scientific data into a cohesive format for the protocol 

document and associated procedures that are consistent with internal and external policies and regulatory requirements.  

•    Participates in other protocol development activities and executes other assignments as warranted and assigned. 

Accountabilities 

•   Ensures that patient safety is protected and monitoring participant progress through the study 

•   Monitors investigator activities to ensure that research projects remain on schedule and within budget 

•   Creates and implements recruitment strategies for research studies 



 

Experience :-  

Required: 

•   Minimum of 1 year of experience in clinical research setting or related field required. 


Desired: 

•   N.A. 

 Educational Qualification: Required: 

•   Bachelor’s level training in one of the science disciplines. 


Desired: 

•   Master’s, nursing degree, or PhD. 

•   Graduate or diploma from a study coordinator training program is preferred