Clinical Research Coordinator

Description

The Clinical Research Coordinator will be responsible for the administrative duties and coordination efforts required in a medical research program. To perform the job successfully, an individual must be able to perform each essential responsibility satisfactorily. These requirements are representative, but not all-inclusive, of the knowledge, skill, and ability required of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Follow research protocols to perform administrative duties for research according to the IRB and FDA regulations
• File Institutional Review Board (IRB) and Food and Drug Administration (FDA) applications
• Maintain all IRB, sponsor, and FDA files and records
• Screen research candidates for enrollment eligibilities
• Perform clinical research tasks such as consenting patients for research studies and collecting research study-related data
• Coordinate and track study progress from beginning to completion, in accordance with study protocols, including but not limited to, subject screening, informed consent, enrollment, visit scheduling, etc.
• Assist in data reporting and electronic entry in data system
• Maintain consent, enrollment and device logs
• Assist in monitoring research data entry internally, and with the collaborating institutes
• Assist in communication with the IRB, sponsors, the FDA and research subjects
• Provide varying operation support to research and Foundation management in the day-to-day conduct of clinical research

Requirements

EDUCATION, EXPERIENCE & CREDENTIALS

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Clinical Research Management, Clinical Research Administration or a healthcare-related field
• One (1) year of clinical research experience

PREFERRED:

• One (1) year experience with Angiographic images
• Familiarity with a healthcare environment
• Certified Clinic Research and Collaborative Institutional Training Initiative (CITI)
• Registered Nurse (RN) or Licensed Practical Nurse (LPN)

KNOWLEDGE, SKILLS & ABILITIES

• Highly proficient in Microsoft Office (Outlook, Word, Excel, and PowerPoint)
• Proficient computer skills to process, store and retrieve health information; knowledge of data entry and coding software
• Strong knowledge of medical terminology
• Effective communication, both oral and written
• Ability to learn quickly when facing new problems or in obtaining new information; quickly grasps the essence and the underlying concepts
• Ability to complete work in a timely manner while maintaining a high level of detail and accuracy
• Can manage various responsibilities with multiple deadlines and competing demands
• Experience developing and maintaining logs and tracking mechanisms for documentation and activities•Works with a high level of autonomy
• High level of confidentiality and discretion
• Knowledge of the current research governing regulations and policies
• Ability to travel frequently, locally

PHYSICAL REQUIREMENTS:

These physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this position. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of the job. While performing these responsibilities the employee is required to talk and hear. The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 10 pounds. Vision abilities required by this job include close vision.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The work area is fully equipped, well-lit and ventilated. Both nonhazardous and hazardous equipment is present. This position involves Category 1 occupational exposure to blood and other potentially infectious body fluids and material. The noise level in the work environment is usually moderate. Interaction with others is constant and interruptive.