Description

Responsibilities/Duties/Functions/Tasks:

• Assists the Study Team, as needed in communication of study requirements to all individuals involved in the study.

• Works with the Study Team, as needed to develop and implement recruitment strategies by TDDC RESEARCH and IRB requirements and approvals.

• Assists the Study Team as needed in the screening of subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

• Assists Study Team as requested to register participants in the Merge Clinical Trial Management System to ensure billing of study procedures to appropriate funding source.

• Maintains an adequate inventory of study supplies. If handling investigational drugs/devices, follow the sponsor protocol and/or TDDC RESEARCH Policy on Investigational Drug/Device Accountability.

• Assists Study Team in completing study documentation and maintenance of study files by sponsor requirements and TDDC RESEARCH policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.

• Aids the Study Team in maintaining effective and ongoing communication with the sponsor, research participants, Director, and PI during the study.

• Works with the Study Team to manage the day-to-day activities of the study including problem solving, communication, and protocol management.

• Collects and reports ongoing patient recruitment/ enrollment metrics to the Director and PI.

• Arrange secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer.

• Assists the Study Team in the protection of the rights and welfare of all human research participants involved in research by Federal regulations 

• Cooperates with TDDC RESEARCH compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.

• Review and update TDDC RESEARCH Study Workflow Chart and enter all patient visit data in e-CRF and Merge CTMS daily.

• Other duties as assigned.

Education: High school diploma or equivalent. Some college preferred.

Experience: Minimum two years of experience with a healthcare organization.

Requirements

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, and 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. 
• Must be able to lift to 25 lbs.
• Must be able to travel and MVR.
• Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.
• Work Environment: The position is in a well-lighted medical office environment. Occasional evening and weekend work.
• 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.