Lightship is the premier provider of enterprise level, decentralized clinical research services. In this capacity, Lightship serves as a telemedicine-enabled virtual site within a clinical research study. Through the use of technology and home visits by our nurses and other medical professionals, Lightship decentralized model makes participation in clinical research exceedingly more accessible for patients. By placing patients at the center of the decentralized model, Lightship positions patient’s home as the hub for clinical trial activities eliminating frequent study-related visits to clinics and hospitals.
Lightship’s Clinical Research Nurse Manager ensures the integrity and quality of all clinical research activities performed by Lightship nurses for studies conducted by Lightship on behalf of sponsors, under the guidance and oversight from the Principal Investigator (PI). The Clinical Research Nurse Manager also ensures that the services provided by Lightship nurses are conducted in accordance with local regulations, Ethics Committee approvals, and Lightship’s policies and procedures. This individual is accountable for the timely and accurate completion of study visits, study procedures, study assessments, and collection of information from study patients according to protocols. Clinical Research Nurse Manager is accountable for developing processes and procedures to ensure the health, safety, and wellbeing of research patients are protected while patients are enrolled in a decentralized study. The Clinical Research Nurse Manager also assists in managing the relationship with home health vendors (e.g., nursing vendors, phlebotomy vendors, staffing agencies, etc.) and, as needed, performs study coordinator tasks per delegation for limited studies and / or activities.
As a key member of the UK team build, Lightship’s Clinical Research Nurse Manager will also be required to support registration with the Care Quality Commission (CQC) and ensure that our service continues to meet the fundamental standards outlined by the regulator, once registered.
This position is remote, and a successful candidate possesses a willingness and desire to work collaboratively with other functions within Lightship and in addition independently without significant supervision. Additionally, this position requires moderate travel (approximately 30%).
We would like to offer you:
- An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core
- The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade direct-to-patient clinical research solutions at scale
- An unmatched opportunity to grow as part of an early stage startup with industry veterans, high-caliber investors, and a massive market opportunity
- Competitive compensation
Generous benefits package, including:
- Top notch private supplemental healthcare (medical, dental, and vision) for you and your family, effective on day one of employment.
- Generous Holidays Policy (25 days), plus public bank holidays and bereavement to help support work life balance.
- Company sponsored group pension program w/ company contribution.
- Generous paid parental leave
- Income Protection
Clinical Research Nurse Manager is responsible for:
- Recruiting and maintaining an adequate number of competent nursing staff to conduct clinical research studies in compliance with all legal, regulatory, company, and departmental requirements
- Acting as the primary day-to-day contact between Lightship and our home health agency partners in respect to nursing services; ensuring that operations are on track and productive; resolving any issues and escalating any concerns, as they arise
- Acting as the CQC Registered Manager for Lightship, overseeing day-to-day delivery to ensure it continues to meet the fundamental standards set out by the regulator, in collaboration with the Clinical Operations team
- Developing, maintaining, and monitoring nurse resourcing plans for assigned studies
- Evaluate study protocols for nursing requirements
- Directing / coordinating nursing efforts to increase efficiency
- Developing and implementing ongoing training programs for nursing staff
- Collaborating with head of functional area and human resources personnel to provide counseling or performance improvement of nursing staff as needed
- Tracking the status of all required licenses, certifications, and any required competencies for all nursing personnel and home health vendors
- Managing and leading staff to develop collaborative working relationships within the functional area and across Lightship business units as applicable
- Managing the budget and expenses related to nursing services offered by internal nurses and / or home health care partners
- Oversee high quality conduct of research visits with patients in home and in some instances at clinic settings per protocol requirements
- Ensures compliance with each study’s protocol by overseeing Lightship nurses and quality of care delivery at each patient visit
- Participate and oversee recruitment and selection of study patients by interviewing and documenting medical history / medication history per protocol requirements as performed by Lightship nurses.
- Ensure timely notification of Principal Investigator of findings / issues / possible adverse events
- Providing patient education and study instructions to study patients to ensure understanding of study procedures
- Documenting study data in patient records (paper and electronic, as applicable) to capture protocol requirements
- Oversee development of study specific nursing manual for studies conducted in the UK.
Clinical Research Nurse Manager has:
- Required knowledge, skills, and abilities
- Coach, mentor, manage, and train nursing staff
- Strong people skills and the ability to work with teams across customers
- Ability to represent nursing in all internal and external meetings
- Proficiency in standard workplace software (e.g., MS Office) and Electronic Health Records (e.g., EPIC, Cerner, or Meditech)
- Proactively identify competency needs of Lightship nursing staff and develop plans to address them
- Actively involved in development of training material for nurses and study patients
- Develop study specific and departmental clinical assets
- Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative and leadership is imperative
- Ability to start from scratch, execute quickly and accurately without pre-defined processes and protocols, and an interest in defining such processes for the future
- Ability and patience to adapt to patients’ and customers’ preferences and processes, while always upholding Lightship’s standards
- Demonstrated ability to manage multiple clinical studies and function independently
- Education and experience
- Current valid Registration with no limitation to practice within the Nursing and Midwifery Council
- Knowledge of nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG / EKG, administering injections, etc.)
- Knowledge of medical terminology, drug calculation skills, and clinical medicine
- Five (5) years of recent clinical nursing experience in a hospital, clinic, or similar health care setting
- At least five(5) years of sponsored clinical research experience
- Minimum of a diploma from an accredited nursing school, required
- Bachelor of Nursing or another Science degree preferred, or requisite combination of education, training, and experience
- Clean full UK driving license
Our commitment to diversity & inclusion:
Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law.
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