Local Contractor Vendor Research Nurse

Description
Local Contractor Vendor Research Nurse - Belgrade (Serbia)

Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth are experts with experience across all study phases and in a diverse range of therapeutic areas.

Illingworth Research Group is a global organization operating in over 45 countries, bringing clinical research directly into the home of the patient, to improve the experience of patients involved in clinical trials and the quality of their lives.

Job Responsibilities

• Fully conversant with the trial protocol, Case Report Forms (CRFs/eCRF), off-site manual (if

applicable), supporting documents, procedures, and timelines to enable day to day running of the trial

including all relevant SOPs.

• Communicate effectively with the Illingworth research nurse project manager (RNPM), Research nurse

manager, site staff and the Principal Investigator, to ensure a smooth and efficient flow of information.

• Maintain accurate documentation including electronic transfer of data as per Illingworth SOPs

throughout the trial, ensuring subject confidentiality, adhering to GCP and data protection requirements.

• Attend Site Initiation Visits (SIV) as required and any other necessary meetings, including multidisciplinary,

project management and client-facing meetings.

• Coordinate (working with the RN team) and complete subject trial visits on- and off-site. Ensure all trial

related procedures and assessments are completed according to the protocol and relevant SOPs and

that data is collected accurately.

• Administer trial medication as per the protocol, and facilitate the safe storage, transfer, and

accountability of trial medication in accordance with Illingworth SOPs.

• Process and safely package and dispatch samples, liaising with courier companies and organizations

in line with project requirements and supporting documents.

• Assist in identifying potentially eligible patients for research projects and assist with patient recruitment

into clinical trials providing information and support for those patients for on- and off-site care.

• Ensure the accurate reporting of adverse events (AEs) and serious adverse events (SAEs)/suspected

unexpected serious adverse reactions (SUSARs) to the site team and relevant RNPM, providing support

For Any Additional Follow-up That May Be Required.

• Report any suspected misconduct or fraud to Illingworth and associated companies.
• Where you are performing duties on-site, responsibilities may include those above and the following:
• Assist clinicians in taking consent from subjects or take consent according to the protocol when

delegated to do so.

• Assist with the maintenance of Investigator Site files.
• Facilitate and assist monitoring visits and source data verification (SDV) by liaising with Investigators,

multi-disciplinary research teams, and Client Company representatives (e.g., Clinical Research Associate

(CRA), auditor).

• Understand and comply with the relevant local hospital policies and guidelines.
• Provide support to obtain regulatory approvals e.g., completion and submission of Research Ethics

Committee applications and amendments and local site approvals.

Qualification Requirements

• Registered nurse with a minimum of 2 years' post qualification experience.
• Research and clinical trials experience with GCP certification.
• Knowledge of research design and methodology desirable.
• Experience and knowledge of clinical nursing skills such as Venepuncture and ECG preferable.
• Ability to work autonomously with initiative in a team within a multidisciplinary environment.
• Excellent verbal and written communication skills.
• Ability to prioritize and manage multiple tasks.
• Good working knowledge of computer software including Outlook, Word, Excel, and PowerPoint as a

minimum.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary
Act as a key member of the clinical research nurse team and ensure clinical trials are carried out according to their individual approved protocols. Complete clinical trial visits on-site with Investigator teams, or in an off-site capacity, working remotely visiting patients in their home, workplace, or other suitable and safe location. Work in accordance with Good Clinical Practice (GCP) guidelines, Code of Professional Conduct, (or country equivalent), Directives and other regulatory, national, and local requirements.