Clinical Research Coordinator II

Conformance Statements 

In the performance of their respective tasks and duties all employees are expected to conform to  the following:  

• Perform quality work within deadlines with or without direct supervision. • Interact professionally with other employees, customers and suppliers. • Work effectively as a team contributor on all assignments. 
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations. 

Position purpose 

The Clinical Research Coordinator (CRC) is a specialized research professional working with  and under the direction of the Site Manager and Principal Investigator (PI). The CRC supports,  facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct  of the study.  

Responsibilities/Duties/Functions/Tasks: 

• Regular communication of study requirements and changes to relevant members of study  staff. Implements recruitment strategies to prescreen, screen, and enroll subjects in active  trials. Screen subjects for eligibility using protocol specific inclusion and exclusion  criteria, documenting each potential participant’s eligibility or exclusion. 
• Acts as a point of reference for study participants by answering questions and keeping  them informed of study progress.

General Business 

• Ensure relevant study and subject specific information is entered into the CTMS system  on a regular basis. Maintains adequate inventory of study equipment and supplies onsite  at all times.  
• Complete study documentation and maintenance of study files including, but not limited  to, consent forms, source documentation, progress notes if applicable, case report forms,  and investigational accountability forms. 
• Maintains ongoing communication with sponsor, research participants, Site Manager and  PI throughout the course of the study. 
• Manage the day to day activities of the study including problem solving, communication  and protocol management. 
• Ensure all safety data is reviewed by the PI in a timely manner. 
• Protects the rights and welfare of all human research participants involved in research. • Other duties as assigned. 

Qualifications 

Education: Bachelor’s Degree preferred 

Experience: Minimum 2-3 years of Clinical Research coordinating experience required. Experience in phlebotomy preferred 

Other Requirements: None 

Performance Requirements: 

• Knowledge of grammar, spelling, and punctuation.  
• Knowledge of purchasing, budgeting, and inventory control.  
• Skill in taking and transcribing dictation and operating office equipment. • Skill in answering the phone and responding to questions. 
• Skill in time management, prioritization, and multitasking. 
• Skill in writing and communicating effectively. 
• Ability to work under pressure, communicate and present information.  • Ability to read, interpret, and apply clinic policies and procedures.  
• Ability to identify problems, recommend solutions, organize and analyze information.  • Ability to multi-task, establish priorities, and coordinate work activities. • Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and  appropriate practice management software. 

Equipment Operated: Standard office equipment including computers, fax machines, copiers,  printers, telephones, etc. 

Work Environment: Position is in a well-lighted medical office environment. Occasional  evening and weekend work.

General Business 

Physical Requirements: Must possess the physical and mental abilities to perform tasks such as  sitting for 90 percent of the day; manual dexterity to operate office machines including computer  and calculator; stooping, bending to handle files and supplies; and mobility to complete errands  or deliveries. Stress can be triggered by multiple staff demands and deadlines.