Job Description
Research Nurse-SKC-Research Centre
Job Description
Reporting to the Senior Research Nurse and working in close collaboration with the Principal Investigator this position is responsible for the coordination and implementation of assigned clinical trials within the research program. The research nurse will work in collaboration with Nursing Research Committee to support nursing research activties in SEHA facility.
The Research Nurse will facilitate the implementation of clinical trials carried out by the Department involving both in patients and outpatients. He/she will assist the principal investigators in coordinating all phases of the research study, whilst supporting the patients enrolled and their families throughout the treatment plan.
He/she will use a variety of resources and strategies to manage the care of patients participating in clinical trials, ensuring compliance with protocol procedures, assessments, and reporting requirements as well as management of symptoms. He/she will ensure collection of source data and completion of documentation that validate the integrity of the conduct of the clinical trial according to study protocol
The Research Nurse adopt adherence to ethical practices during the conduct of clinical trials in order to protect the rights and well-being of patients and the collection of quality data.
The Research Nurse will advocate for patient safety and trial integrity.
Responsibilities
Responsibilities Protocol Compliance
- Identifies the requirements of various types and phases of clinical trials, including objectives, sample sizes, and patient care needs.
- Identifies sources for and facilitates adherence to current regulations, guidance, and policies that affect research at the institutional, state, national and international levels.
- Promotes compliance with the varied processes and procedures required by different types of sponsors (e.g., private industry, investigator-initiated).
- Protects patient, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
- Participates in discussions regarding feasibility of protocol implementation based on knowledge of institutional capabilities and limitations, therapy, or population of interest.
- Provides education related to clinical trials to patients and their significant others.
- Advocates for the safety and care of clinical trial patients as well as for the promotion and integrity of the clini-cal trial.
- Complies with the International Air Transport Association and institutional policies for shipping and receiving biological specimens, experimental agents, and devices.
- Collaborates with the research team to implement procedures for maintaining patient study participation from enrollment through completion.
- Participates in providing timely, informative, and accurate communication as required.
- Ensures validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events.
- Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for experimental devices or drugs as indicated
- Advocates for Nursing Research and work closely with nurses to conduct Clinical Nursing Research projects
- Advice and help nurses in submitting Nursing Research Proposals to ethics committee
Ethical Issues
- Advocates for ethical care of clinical trial patients and the conduct of clinical trials in accordance with standards of nursing practice.
- Promotes ongoing compliance with key ethical concepts by the research team, including informed consent, documentation, and respect for persons, beneficence, and justice.
- Ensures that members of vulnerable populations enrolled in clinical trials are identified and that their rights are acknowledged.
- Identifies and follows institutional procedures to report any falsification of data or scientific misconduct evidenced by any member of the research team
- Ensure that nurses are following appropriate ethics standards in conducting nursing research studies utilizing Good Clinical Practice
Financial Implications
- Confers with the principal investigator and finance personnel when protocol revisions will affect the costs of protocol management.
- Identifies routine care versus research-related costs, the financial impact on patients, and any need for financial counseling.
- Ensures and tracks submission of specified items (e.g., completed case report forms, specimens) to facilitate timely recovery of protocol-related activity costs.
- Ensures that stipends to patients for protocol-related activities are disclosed to the IRB during approval of the consent form
Professional Development
- Participates in educational opportunities to increase knowledge about clinical trials, regulations and guidance, and the role of the Research Nurse.
- Seeks resources on an ongoing basis that provide oncology treatment and nursing practice updates, such as through professional mentoring and meetings, journals, and Web sites.
- Contributes to annual appraisal and is responsible for own Professional Development Program
- Participate in Nursing Research Workshops and Nursing Conferences
Documentation
- Complies with regulations, institutional policies, and sponsor requirements governing source data and docu-mentation.
- Documents assessment, management, and evaluation in source documents for patients on clinical trials as ap-propriate to the protocol and role.
- Ensures relevant data from the source document are recorded in the clinical trial case report forms and that every data point can be verified within the source document.
- Follows appropriate guidelines in making corrections to data entry in clinical records and case report forms as recommended by good clinical practices, standards, or institutional procedures.
- Ensures that all regulatory documents are processed and maintained per institution and best practice regula-tions.
- Ensures the initial and ongoing consent process is performed by the physician who is the principal investigator and documented in compliance with best practice, the institutional, sponsor, IRB, and other applicable regulations and hospital policies.
- Participates in the education of clinical trial patients and their families about their clinical trial and significant new information that is forthcoming during or after the conduct of the trial.
- Assesses for barriers to effective informed consent discussions and implements plans to overcome them
- Keep documentation of all Nursing Research Activities at SEHA facility
Patient Care and Management
- Collaborates with the principle investigator to ascertain study patient eligibility for a clinical trial, including documenta¬tion of criteria specified in the protocol.
- Ensures adherence to the protocol schedule of events and other requirements.
- Ensures scheduling of all procedures required to assess for adverse events and disease response to the study intervention.
- Assesses patients for trial-related and non–trial-related symptoms and ensures evidence based symptom management in collaboration with the principal investigator while maintaining trial compliance.
- In collaboration with the investigator, assesses patients for adverse events and then documents and reports these findings per the protocol, sponsor, and IRB policies.
- Evaluates disease response results and physical assessment data in conjunction with the principal investigator to determine response per the protocol.
- Supports and evaluates patient adherence to the protocol by utilizing various methods to assist with documenta-tion, patient education, and study agent return.
- Identifies vulnerable patients who require increased nursing assessment and management in addition to the clinical trial requirements.
- Performs basic nursing procedures such as phlebotomy, vital signs specific to the study. May administer treatments specific to the study in collaboration with a 2nd registered nurse.
- Ensures registered nurse caring for the patient is aware of any intervention or change in patient status
- Help to improve patients conditions by answring clinical research questions to provide evidanced based clinical practice
Communication
- Keep record of all communication between sponsor and investigators.
- Provides general clinical research as well as trial-specific information to research, clinical, and other organiza-tional staff.
- Develops relationships with referring physicians, clinical staff, and ancillary departments to facilitate compli-ance with clinical trials
- Develops strong communication with nursing department to advocate for nursing research between nurses.
- Participates in study initiation meetings.
Qualifications
Qualification :-
Special Certificate:-
Required
- A total of 5 years post qualification inclusive of 2 years’ experience as a charge nurse
- UAE Nurses: A total of 4 years post qualification inclusive of 1 year experience as a charge nurse
About Us
Abu Dhabi Healthcare Company (SEHA) is the largest and most comprehensive healthcare network in the UAE that was established in 2007 with the objective of operating all public hospitals and clinics across the Emirate of Abu Dhabi.
SEHA is committed to delivering world-class healthcare services using the most advanced diagnostics and systems across its network of public healthcare centers and hospitals in addition to partnering with global leaders in healthcare, including world renowned organizations such as the Mayo Clinic.