RN Clinical Research

Clinical Trial Coordinator

This job evaluates, initiates, and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility in coordination and collaboration with principal investigators. Communicates with external funding agencies, sponsors, departments, and patients to ensure understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all patient care requirements. Provides patient care and assessment as determined necessary by the clinical trial in coordination with other care providers.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.

This job description is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.

Education

Required Associate degree in nursing.

Work Experience Required - 3 years of experience in area of assigned clinical specialty including 2 years performing clinical research, or 2 years of relevant research experience in a clinical setting with ACRP, SOCRA, or relevant professional nursing certification.

Certifications Required - Current registered nurse license in state of practice. Basic Life Support (BLS) from the American Heart Association.

Knowledge Skills and Abilities (KSAs)

• Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
• Working knowledge of ICH guidelines for ethical conduct of research.
• Strong problem solving and critical thinking skills and ability to work independently and in a team environment.
• Ability to follow and provide critical feedback on the investigational plan.
• Ability to train junior staff members standard operating procedures and other related research activities.
• Strong organizational and time management skills and ability to multi-task, pay close attention to detail, and learn new techniques.
• Strong working knowledge of the requirements and regulations associated with the conduct of clinical trials and other related research activity.
• Ability to interpret and carry out all aspects of a protocol including patient eligibility, assessing adverse events and dose modifications, treatment plan, associated required tests and procedures, and all other aspects of the protocol as required.
• Knowledge and execution of the nursing process to assess toxicities from investigational therapies and works with the investigator in management of these adverse events.
• Working knowledge in using computers, software, and web-based applications, including working knowledge of Epic.
• Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts, shifts depending on area of assignment.

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

Remains knowledgeable on current federal, state, and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations, and standards.

This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.

The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Physical and Environmental Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.

Duties performed routinely require exposure to blood, body fluid and tissue.

The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. The incumbent has an occupational risk for exposure to all communicable diseases.

Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role.