Job description

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 Assistant (CRA) is a specialized research professional working with and under the direction of the Director, Clinical Principal Investigator (PI) and Clinical Research Coordinators. The primary responsibility of the CRA is to assist the Clinical Research Coordinators with conduct of research studies. The CRA supports and facilitates the daily clinical trial activities and plays a supportive role in the conduct of the study.

Responsibilities/Duties/Functions/Tasks:

• • Assists 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 in accordance with TDDC RESEARCH and IRB requirements and approvals. • Assists 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 adequate inventory of study supplies. If handling investigational drugs/devices, follows 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 in accordance with 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 sponsor, research participants, Director and PI during the course of 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 Director and PI. • Arranges 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 Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with 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 on a daily basis.
• • Other duties as assigned.

Qualifications

• Education: High school diploma or equivalent. Some college preferred.
• Experience: Minimum two years of experience with a health care organization.

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.
• • Must be able to lift up 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: 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.