Position Title: Clinical Research Associate

Reports To: Vice President, Clinical Operations

Job Summary:

The Clinical Research Associate (CRA) works closely under the direction of the Lead CRA, to ensure investigators are conducting the research within requirements of the clinical protocol. This includes ensuring research is conducted in accordance with applicable federal regulations and guidelines, data quality on initial review meets acceptable clinical standards, and the rights and safety of human subjects involved in a clinical study are protected. The CRA is one of the primary liaisons between clinical investigational site personnel and TCTM.

Major Responsibilities:

· Knowledge of applicable SOPs, guidelines and study procedures

· Training site staff on protocol requirements, proper source documentation and case report form completion

· Conducting regular site visits and writing visit reports

· Ensure compliance with the clinical trial protocol, check clinical site activities, review case report forms (CRFs), and source data verify all on-site data

· Make certain that the scientific integrity of the data collected is protected and verified and assure that adverse events are correctly documented and reported

· Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines

· Review all contents of Site Regulatory Binder and ensure completeness at all times

· Overseeing and documenting IP dispensing, inventory and reconciliation

Qualifications:

· Requires a minimum of a Bachelor’s Degree, preferably in a scientific, healthcare, or related field

· Requires a minimum of two (2) plus years’ monitoring as a CRA at either a CRO or pharmaceutical/biotech company

· Knowledge of pharmaceutical industry, terminology and practices

· Knowledge of FDA regulations and their practical implementation

· Ability to manage and prioritize workload effectively

· CRA certification preferred

· Must have a valid driver’s license

· Willingness and ability to travel up to 75% of the time

· Excellent oral and written communication, organizational and planning skills

· Thoroughness and dealing with complexity

· Proficiency with Microsoft Office Suite

If you are interested in applying for this job, please email your resume to bizdev@totalcro.com.