Clinical Research Assistant

About the Role 

The Clinical Research Assistant (CRA) is responsible for helping to conduct and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations.   

What You’ll Be Doing 

• Administratively and clinically help coordinate with a team to work on a minimum of six clinical trials (level 1-3 clinical research protocol) . Help schedule, plan and participate in study monitoring visits and address any potential queries or deviations in accordance to the study protocol. Acts as a liaison between sponsor and the research department.   

• In collaboration with the Clinical Manager advises treating physicians of clinical protocol opportunities and procedures. Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria. 

• Acts as a study resource for patients and family. Discusses study protocols with patients and verifies the informed consent process and documentation.  Addresses any questions or concerns the research patient may have regarding the study.  Provides patient with written communication of their participation. 

• Ensures subjects understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction.  

• Dispenses study medications in accordance to protocol requirements within his/her scope of practice.  Performs Investigational Product accountability for accurate compliance. 

• Collects, processes and ships blood/urine specimens at scheduled times.

• Contacts outside health care providers and communicates with subjects to obtain follow up information. 

• Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. 

• Ensures filing and maintenance of all regulatory documents. 

• Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums. 

• Maintains required continuing education hours required for certifications. 

• Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS). 

• Maintains a high level of patient confidentiality. 

• Performs all other duties as assigned. 

What We Expect from You 

• Associates or Bachelor’s Degree from an accredited college or university. 

• Good Clinical Practice (GCP) Certificate 

• International Air Transport Association (IATA) Certificate 

• CCRC certification through an accr