Acts as the lead nurse on multiple ongoing clinical trials involving patients or healthy volunteers/subjects, taking overall responsibility thereof at the site, liaising with monitors and other stakeholders. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment and retention of study participants. Provides training and guidance to junior team members.
Essential Functions and Other Job Information: 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 maximized. Performs all defined study activities (i.e., 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 obtained 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 correct 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 stakeholders. 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, overseeing 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.
Education and Experience: Registration with no limitations to practice within the Nursing and Midwifery Council (Adult) Clinical Research experience A team player with well-developed interpersonal and communication skills A patient focussed attitude
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’).
Knowledge, Skills and Abilities: Excellent understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.) Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving Excellent decision-making, negotiation and influencing skills Excellent communication skills and English fluency will be an advantage Excellent organizational skills Essential proficiency in basic computer applications Excellent interpersonal skills to work in a team environment
- Attention To Detail
- Clinical Research
- Clinical Trials
- Coaching And Mentoring