- Acts as the lead and subject matter expert in conducting clinical studies according to FDA/GCP and ICH regulations and guidelines.
- Provides medical care to patients, always ensuring patient safety comes first.
- Schedules subject visits within protocol windows, ensuring scheduling capacity is improved.
- Performs all defined study activities (, informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, blood samples, etc.).
- Records all patient information and results from test as per protocol on the required forms.
- Where required, may complete IP accountability logs and associated information.
- Reports suspected non-compliance to relevant site staff.
- Ensures that IRB approval is acquired prior to study initiation and IRB requirements are met throughout the study.
- Promotes the company and builds a positive relationship with patients to ensure retention.
- Attends site initiation meetings and all other relevant meetings to receive training on protocol.
- Reviews the overall plan for study conduct for multiple assigned studies and determines how to accomplish. Identifies and communicates any obstacles impeding efficient study conduct.
- Accurately collects and documents data. Ensures accurate study documents and computer generated forms are used in compliance with protocol.
- Ensures that timelines are met by working with relevant staff.
- Monitors safety and well-being of all study participants through direct and indirect interaction with subjects, and communicates problems to relevant collaborators.
- Performs clinical assessments of participants, monitors laboratory safety reports, and communicates any serious or potentially serious adverse events as per the company procedure.
- Serves as a primary point of sponsor contact for all research activities for studies assigned.
- Ensures all communications are documented and shared with the appropriate team members.
- Acts as a back-up to direct people manager. This includes but is not limited to, coordinating and assigning work to team members, scheduling, and monitoring time.
- Involved in the interview and hiring process of new team members.
- Assists in the training of new team members and provides mentoring.
- Provides input into evaluations performance reviews of team members.
- Performs other study related duties as qualified by documented training.
- Excellent understanding of the clinical research process (, GCP, SOPs, informed consent, safety monitoring, etc.)
- A qualified Nurse, a registration with no limitations to practice within the Nursing and Midwifery Council (Adult)
- Well-developed interpersonal and communication skills, the ability to work in a cross functional team
- A patient focussed attitude
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Lead Clinical Research Nurse - Hexham, United Kingdom - Thermo Fisher Scientific
Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.Alongside clinical research through our PPD clinical research portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.
We are currently looking to recruit a for our Synexus Clinical Research site in Hexham, United Kingdom
We pride ourselves on being the "Patient's choice for clinical research" and our Nursing teams are directly involved with ensuring a continuity of care for patients during the studies.
As a Lead Clinical Research Nurse you will be a key member impacting the development and research for therapeutics for patients. You will act as the lead coordinator on multiple ongoing clinical trials, collaborating closely with monitors and other stakeholders. You will also be able to provide training and mentorship to junior team members.
Key responsibilities for a Lead Clinical Research Nurse are as follows:
To be considered for this exciting opportunity you will require the following skills and experience:
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
