Clinical Research Coordinator

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The TCRC Clinical Research Coordinator II is part of a team of providers and support staff that support investigators in the implementation and execution of their studies. Responsibilities include IRB submission and amendments, application for service, creation of order sets and flow sheets to mirror the protocol, participant recruitment, scheduling of appointments and other activities as delegated (as per study specific delegation log). Commensurate with experience and motivation, opportunity exists to participate in scientific manuscript preparation and writing. Creative thinking, a willingness to learn new skills, and the ability to handle multiple projects are expected. Knowledge of epic and research scheduling platform. Prior research or work experience is preferred.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Collects & organizes patient data
• Maintains records and databases
• Uses software programs to generate graphs and reports
• Assists with recruiting patients for clinical trials
• Obtains patient study data from medical records, physicians, etc.
• Conducts library searches
• Verifies accuracy of study forms
• Updates study forms per protocol
• Documents patient visits and procedures
• Assists with regulatory binders and QA/QC procedures
• Assists with interviewing study subjects
• Administers and scores questionnaires
• Provides basic explanation of study and in some cases obtains informed consent from subjects
• Performs study procedures, which may include phlebotomy.
• Assists with study regulatory submissions
• Writes consent forms
• Verifies subject inclusion/exclusion criteria
• Performs administrative support duties as required

A Clinical Research Coordinator II performs the duties of a Clinical Research Coordinator I (above) and may also:

• Maintain research data, patient fields, regulatory binders and study databases
• Perform data analysis and QA/QC data checks
• Organize and interpret data
• Develop and implement recruitment strategies
• Act as a study resource for patient and family
• Monitor and evaluation lab and procedure data
• Evaluate study questionnaires
• Contribute to protocol recommendations
• Assist with preparation of annual review
• May assist PI to prepare complete study reports

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Careful attention to details
• Good organizational skills
• Ability to follow directions
• Good communication skills
• Computer literacy
• Working knowledge of clinical research protocols
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs

The Clinical Research Coordinator II should also possess:

• Ability to work independently and as a team player
• Analytical skills and ability to resolve technical problems
• Ability to interpret acceptability of data results
• Working knowledge of data management program

EDUCATION:

• Bachelor's degree required.

EXPERIENCE:

• New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.
• Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.

SUPERVISORY RESPONSIBILITY (if applicable):

• A Clinical Research Coordinator I does not have any supervisory responsibility.
• A Clinical Research Coordinator II may assist with the training and orientation of new staff members.