Essential Functions and Job Duties

•  Coordinates screening and enrollment of clinical trial patients.

• Reviews physician patient schedules and assesses patients for possible clinical trial enrollment.
• Educates patients and families during the informed consent process.
• Registers patients and participants to protocols.
• Ensures eligibility requirements are met and reviews with physician investigator.
• Ensures protocol required patient testing is ordered and complete.
• Maintains record of recruitment strategies.
• Markets protocols as needed to meet recruitment goals.

• Coordinates clinical trial activities research done at the clinic and hospital

• Gathers and verifies source documents
• Verifies the accuracy, completeness and timely submission of case report forms.
• Collaborates with investigator to ensure protocol compliance in patient selection, treatment, dose modifications and response.
• Interviews patient to assess adverse events, medication compliance, and patient reported outcomes.
• Obtains follow-up data required when patient is off active treatment.
• Corrects and resubmits data or answers queries within one week of receipt or as requested by pharmaceutical company; reviews expectation reports; notifies research base of errors.

• Maintains investigational drug (IND) inventory
• Reviews protocols and assesses current inventory of IND.
• Orders INDs from Pharmaceutical Management Branch at National Cancer Institute.
• Maintains inventory on individual drug accountability records.
• Ensures treatment order is correct by reviewing protocol guidelines and calculating dose prescribed.

Qualifications

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. 

• Must possess good communication and interpersonal relationship skills.  Must be able to organize work with minimal supervision.  Must be able to focus attention to minute details.  Access, Work and Excel computer skills required.

Education and/or Other Requirements

A bachelors degree in nursing or other health-related field is preferred.  Pertinent LPN or RN licensure/registration must be maintained.  Previous research experience and/or recent nursing experience is preferred.

Environmental Factors

Direct patient care duties involve the potential for frequent exposure to blood and body fluids.

Physical Demands

The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Light physical exertion, including occasional standing, bending, reaching and occasional carrying of light loads.

Mental Demands

• While performing the duties of this job, the employee must be able to work under stress, adapt to changing conditions and meet strict time guidelines.

• Ability to adhere to strict confidentiality requirements.

1. Anticipates the needs of patients and their families and serves as a link between hospital departments, physician offices and outside agencies to connect patients to the resources and programs that will meet their disease and individual needs based on the research protocol.

1. Works closely with physician offices to provide physicians, office staff, and patients a seamless entry for clinical services from the office setting to the services necessary for the patient in the research protocol.

1. Coordinates the physician and nursing care plans between settings via personalization and customization to enhance the patient experience.

1. Prepare and submit written adverse drug reaction reports to the NCI and research bases as required.
2. Embodies the Memorial Health System Performance Excellence Standards of Safety, Courtesy, Quality, and Efficiency that support our mission, vision and values:

• • SAFETY: Prevent Harm - I put safety first in everything I do.  I take action to ensure the safety of others.
  • COURTESY: Serve Others - I treat others with dignity and respect.  I project a professional image and positive attitude.
  • QUALITY: Improve Outcomes - I continually advance my knowledge, skills and performance.  I work with others to achieve superior results.
  • EFFICIENCY: Reduce Waste - I use time and resources wisely.  I prevent defects and delays.

1. Serve as a liaison between Memorial, the research bases, the Heartland NCORP (National Cancer Institute Community Oncology Research Program), and the individual investigators (physicians).

1. Serve as a professional resource and/or instructor regarding clinical trials, protocol procedures, and protocol compliance for investigators, nurses, pharmacists, pathologists, radiologists, and other health care personnel both inside and outside of Memorial.

1. Coordinates the timely scheduling of tests, procedures, appointments and treatments.

1. Assist investigators in developing individual office systems to make protocol procedures convenient and help ensure protocol compliance.

1. Responsible for data management activities that relate to any research studies coordinated through the Regional Cancer Center.

• • Patient screening and determining eligibility.
  • Obtaining informed consent and patient teaching.
  • Registering patients on research studies.
  • Clinical follow-up and data submission maintenance.
  • Quality control regarding documentation, protocol compliance, and data submission requirements.
  • Evaluations and analysis of research/data management activities.

1. Maintain a record keeping system that documents patients registered on research studies, their protocol status, and copies of the informed consent, source documents and the data submitted.

1. Order and monitor investigational and provided drug inventories and drug accountability records in central and satellite pharmacies.

1. Delegate/prioritize responsibilities when appropriate due to fluctuations in workload.

1. Attends general and site-specific cancer case conferences to identify patients who can benefit from research protocols and opportunities for Memorial to improve cancer care delivery services.

1. Represent Memorial’s Regional Cancer Center’s policies and philosophy to others.

1. Train new employees of research division in protocol coordination activities and data management.

1. Coordinate and/or assist with clinics designed to collect research data.

1. Coordinate and manage selected pharmaceutical trials as assigned.

1. Promotes programs and resources of the Regional Cancer Center and Memorial Health System to patients and families, hospital departments, and physician partners.

1. Observe institutional and federal regulations related to informed consent and scientific integrity of research.

1. Identifies gaps in patient care experiences and modifies interventions and service offerings to accommodate patient needs.

1. Coordinates patient care with inpatient and clinic nursing staff and patient care facilitators to anticipate patient needs and plan for coordination of services following discharge.

1. Perform additional duties and responsibilities as required by the Administrator and program Director.

1. Performs other related work as required or requested.

The intent of this job description is to provide a representative summary of the major duties and responsibilities performed by incumbents of this job.  Incumbents may be requested to perform tasks other than those specifically presented in this description.