Careers

OPEN POSITIONS

 

Clinical Research Coordinator

The purpose of the position is to serve as clinical research coordinator to fulfilling the overall functions of a Coordinator for single- and multi-site studies.  The Research Coordinator is responsible for managing the day-to-day operations of clinical and laboratory-based research projects and activities including recruitment and enrollment of new participants into the study, the collection of clinical data, as well as biological sample collection and analysis.  

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Major Duties:

• Work with Principal Investigators (PIs) in conducting clinical research.

• Help in writing research grants, literature search, and introducing new ideas to conduct new clinical trials. 

• Work with patients to prioritize them for participating in clinical trials. 

• Ensure study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents while obtaining relevant medical information from patient clinic charts/medical records.

• Analyze clinical data to understand treatment response and disease characteristics. 

• Work with administrative staff and clinical research coordinators to help run the clinical trial smoothly. 

• Work with PIs to write and publish articles in scientific journals. 

• Carry out various data processing tasks using statistical methods to help understand the research question.

• Update databases and work on analyzing data using database user interface and query software: Redcap, Medidata, Covance, etc.

• Ensure compliance with Standard Operating Procedures (SOPs) and local regulations, and follow Good Clinical Practice (GCP) guidelines. 

• Maintain protocol-specific study documentation as required in the management of study patients, as per federal regulations and sponsor requirements. SOPs while maintaining logs to track progress reports to both currently enrolled as well as follow-up participants.

• Record and report Adverse events (AEs), Severe Adverse Events (SAEs) and Unanticipated Problems (Ups) in compliance with federal regulations, the protocol and policies to the sponsor and/or IRB as directed by the PI.

• Read, analyze, and interpret information from professional journals, technical procedures, or governmental regulations. 

• Plans, implements, and maintains data collection and analysis systems in support of research protocol, and also organize the collection and analysis of research data. 

• Identify data sources, compile and preparing data for analyses using statistical programming languages like R and using software like Excel. 

• Assist with grant and IRB submissions.

• Working with laboratories regarding research findings.

• Maintaining detailed records of studies as per FDA guidelines, protocol requirements including things such as drug dispensing. 

• Assist with and coordinate initial budget and contract negotiations with study sites. 

• Protect and maintain subject’s confidentiality, update their information and verify if subject is adhering to study requirements. 

 

Qualifications:

• Advanced degree in social or biological sciences; education in research methods and statistics; experience in health care setting.