Clinical Research Associate II/Sr. (1027)

FLSA Classification: Salary, Exempt 

Schedule:  Monday - Friday; 8:00 am - 5:00 pm; preferred Northeast region of USA 

Department: Clinical Operations 

Reports to: Associate Director, Clinical Operations  

Supervisory responsibilities: No 

Location: Remote or office based in Houston at 13203 Murphy Rd., Stafford, TX 77477 

 Position Summary/objective: 

Responsible for the clinical monitoring activities for assigned clinical trial sites in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality and timely delivery.  

Essential functions: 

• Support clinical trial site feasibility. 

• Conduct all aspects of clinical monitoring for clinical trials including site visits for qualification, initiation, routine monitoring and close-out.  

• Conduct all aspects of site management as prescribed in the clinical trial specific functional plans. 

• Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiate appropriate actions to achieve objectives. 

• Support the maintenance of the Investigator Site Files and Trial Master Files 

• Prepare accurate and timely monitoring visit reports.  

Secondary functions: 

• Maintain clinical trial tracker.  

• Organize and present content at Investigator Meetings 

• Participate in the development of Case Report Forms and clinical trial documents. 

• Act as contact for clinical trial supplies and other suppliers (vendors) 

• Prepare and review Standard Operations Procedures and Working Instructions as well as template documents.  

Competencies: 

• Excellent communication (written/verbal) skills.    

• Positive attitude and willingness to learn and contribute in a team.   

• Excellent organizational skills to work efficiently, good time management.  

• Exceptional attention to detail   

• Team player with excellent negotiation and conflict resolution skills   

• Demonstrates ability to take initiative and work independently.  

• Ability to prioritize and adapt quickly in a fast-paced and changing industry.  

• Outside the box thinking and a high degree of flexibility in an environment which is marked by a constant striving for excellence  

Work environment: 

This position is remote and should be performed in an office setting