Clinical Research Nurse Leader

POSITION SUMMARY:

Job Summary: Provides direct care to research study participants and makes necessary nursing judgments. Uses the nursing process to deliver professional care and evaluation of study participant responses to study protocols and works closely with faculty, fellows, residents and nursing staff.

KEY RESPONSIBILITIES:

Provides direct care to research study participants, including patients and volunteers, and makes necessary nursing judgments. Demonstrates clinical performance at an expert level utilizing perceptual skills which are intuitive, or experience based. Critiques own decision making and judgments regarding the care of patients.

Demonstrates greater depth in practice focus, providing nursing consultation for atypical patient presentations, unexpected events or unusual outcomes, recurring problems on the patient care unit, or strategic planning for the future of the unit. Evaluates the results of consultation in terms of patient outcomes and ability of the consultee to handle similar problems in the future

Coordinates the care of patients and directs assistive personnel in order to provide safe, effective, efficient, equitable, and timely, patient centered care. Identifies problems and populations at risk and proposes solutions

Works in a collaborative relationship with other health professionals to determine health care needs of patients & families. Demonstrates & role-models an interdisciplinary collaborative approach to patient care. Utilizes negotiation & conflict resolution skills to foster collaborative and collegial relationships. Participates in quality improvement activities & other clinical investigations.

Participates in activities that contribute to the ongoing development of self and others. Responsible for maintaining annual mandatory educational requirements, which include emergency skills and unit-based competencies. Self-evaluation of practice unexpected outcomes are identified, and other courses of action are considered

Research nurses can also be expected to perform the following tasks:

• Compile clinical data and enter it into a database
• Review and assess data collected
• Collaborate with investigators and statistical consultants
• Screen and recruit subjects for clinical studies
• Assist with surgical procedures as needed
• Provide care to all study subjects within the standards set forth by eStudySite and Partner facilities.
• Safely and effectively administer study medications.
• Accurately document the administration of study medication in the source document and MAR sheet (for inpatient).
• Captures pertinent data onto source documents (i.e., vital signs, adverse events, concomitant medications, etc.)
• Reports and documents serious adverse events on a timely manner.
• Screens and enrolls patients according to specific protocol requirements.
• Responsible for gathering necessary information from the research participants (i.e. HIPAA, Medical Chart Release Authorization, Questionnaires).
  Responsible for the Informed Consent Process per the SOPs.
• Responsible for reviewing inclusion and exclusion criteria for the PI.
• Responsible for completing all study specific procedures according to the study protocol.
• Review subject’s information in preparation for the investigator’s review.
• Responsible for completing source documents and assisting the study coordinator with data transcription onto the Case Report Form (CRF)
• Ensure the diagnostic specimens are packaged per IATA guidelines * Screens all inpatients daily for all open studies and enrolls patients according to specific protocol requirements
• Completes medical trials electronic daily screening/enrollment log daily.
• Assist in any additional tasks assigned by Management

REQUIRED KNOWLEDGE & SKILLS:

• Able to work overtime to ensure subject safety and maintain the integrity of research studies
• Knowledge of Medical Terminology.
• Knowledge of OSHA requirements.
• Able to stand for long periods of time.
• Able to work in a fast-paced environment.
• Excellent verbal, written and organizational skills.
• Excellent phlebotomy skills.
• Self-motivated.
• Ability to maintain ongoing knowledge of all current research protocols.
• Ability to be a team player.
• Excellent interpersonal and communications skills.
• Ability to work independently.
• Extreme attention to detail.
• Critical thinking skills
• Knowledge of microbiology and infectious disease.
• Open minded and always willing to learn
• Flexible, able and willing to make changes in work schedule to meet the demands of the company.
• Working knowledge of safety regulations.
• Working knowledge of HIPAA compliance
• Preferred Qualifications:
• Experience in a teaching hospital and specialty area expertise
• Supervised clinical experience in a research environment might be available through nursing education programs.

Competencies:

• Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers.
• Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.
• Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
• Teamwork: Ability to act as a team leader for small projects or work groups, creating a collaborative and respectful team environment and improving workflows. Results may impact the operations of one or more departments.
• Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.
• Age based Competencies:
  Employees in this job must be competent to provide patient care to the following age groups: Young adult: 16-30 years, Middle Age: 30 - 60 years, Elderly: 60 -.
  
• Physical Nature of the Job:
  Medium work: Exerting up to 50 pounds of force occasionally and or up to 20 pounds of force frequently. Job is physical in nature and employee needs to stand and/or move around through most of their shift.

• The physical demands of the job 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 qualified disabilities to perform the essential functions.
• Ability to travel locally.
• The ability to sit for several hours at a time.
• Communicate in person and by a telephone.
• Limited walking required.
• Limited to lifting to 25 pounds.

EDUCATION/EXPERIENCE/LICENSURE/TECHNICAL/OTHER:

Bachelor's degree required in Nursing. Master's degree preferred in Nursing

License required: Nursing License, and Certificate 1 required: Basic Life Support

1-3 years related work experience required.

American Heart Association - Basic Life Support Certificate

Completion of CITI training within 6 weeks of hire and recertification every three years thereafter.

Basic familiarity with computers. Ability to navigate at a basic level within web-based applications.