Manager, Clinical Research Nursing Operations

Overview

Lightship is the virtual-first provider that is perfecting the way clinical trials get executed. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence in clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and in-house patient care team ensure sponsor success and the best possible patient experience. With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship.

Lightship's Manager, Clinical Research Nursing Operations is responsible for managing Lightship's nursing team, vendors, and partners, and overseeing all nursing operations. This role ensures the integrity and quality of clinical research studies conducted by nurses on behalf of sponsors, under the guidance and oversight from the Principal Investigator (PI). This individual is responsible for overseeing the accurate completion of study visits, procedures, assessments, and collection of information from study patients according to protocols and for protecting the health, safety, and wellbeing of research patients; in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Lightship's policies and procedures. The Manager, Clinical Research Nursing Operations sets the strategy, budget and direction for Lightship's nursing function, ensuring that the complex resourcing demands of new and emerging studies are appropriately managed.

This position is remote, and a successful candidate possesses a willingness and desire to work independently without significant supervision. Additionally, this position requires moderate travel (approximately 30%).

The Manager, Clinical Research Nursing Operations & Delivery is responsible for:

• Overseeing that nursing team comply with study protocol, applicable regulations and SOPs and that study remains on track, escalating risks to delivery on time, within budget and to expected quality standards appropriately
• Providing Clinical Leadership with inputs on how best to operationalize new service lines/ capability offerings with nursing involvement e.g., Mobile Research Units (MRU)
• Partnering with Clinical Leadership and the People Team to set and continually review hiring needs based on study demands, and actively participating in the review, selection, and on-boarding of new candidates
• Evaluating study protocols for nursing requirements and working with the study team to agree how best to implement nursing activities
• Supporting the delivery of study-specific nurse training (if required)
• Resourcing study with appropriate personnel, in line with capabilities, licensure and individuals' development goals
• Managing and leading staff to develop collaborative working relationships within the functional area and across Lightship business units as applicable
• Other duties as assigned
• Identifying and building relationships with strategic nursing partners and determining how best to operationalize partnership based on nursing priorities
• Personnel Management:
  • Leading Lightship's nursing team to deliver excellent care to patients, in compliance with all necessary regulatory requirements, ICH-GCP and departmental guidelines and SOPs
  • Developing, maintaining, and monitoring resource plans to ensure that the appropriate number of nurses with the correct capabilities and licensure are available to meet both current and upcoming study demands, achieving optimal utilization of staff
  • Partnering with Clinical Leadership and the People Team to set and continually review hiring needs based on study demands, and actively participating in the review, selection, and on-boarding of new candidates
  • Developing the strategy and budget for day-to-day nursing operations in alignment with Clinical Leadership
  • Developing a strategy for nurse scaling at speed and within budget to respond to evolving client needs, including proactively identifying and evaluating different options for building nursing team across key geographies
  • Identifying and building relationships with strategic nursing partners and determining how best to operationalize partnership based on nursing priorities
  • Define key performance indicators/ metrics for measuring nursing performance and provide Clinical Leadership with regular updates on team performance
  • Acting as the primary day-to-day contact between Lightship and its existing vendors/ partners that support nursing activities (e.g., staffing agencies, equipment, and uniform providers etc.), to ensure service delivery is on track and any issues are resolved
  • Developing, implementing, and delivering ongoing training programs for nursing staff (both general and study specific training), including seeking out appropriate certifications to drive further professional development of team
  • Managing, mentoring, and developing nursing staff, by providing necessary coaching and overseeing performance management to build high performing team
  • 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
• Developing, implementing, and delivering ongoing training programs for nursing staff (both general and study specific training), including seeking out appropriate certifications to drive further professional development of team
• Participating in bids/ proposal development by providing input on study feasibility from a nursing standpoint, as well as helping sponsors/ clients understand opportunities for safely conducting visits outside of the clinic setting in a collaborative manner
• Periodically reviewing participant and investigator feedback surveys and driving necessary changes and improvements to nursing activities if needed
• Define key performance indicators/ metrics for measuring nursing performance and provide Clinical Leadership with regular updates on team performance
• Forecasting and managing study-specific budget and expenses related to nursing services in line with agreed budget
• Acting as a point of escalation for nursing team, helping to resolve study specific risks or issues and ensuring cross functional leads and project managers are kept updated
• Developing, maintaining, and monitoring resource plans to ensure that the appropriate number of nurses with the correct capabilities and licensure are available to meet both current and upcoming study demands, achieving optimal utilization of staff
• Management of Nursing Operations on Study:
  • Evaluating study protocols for nursing requirements and working with the study team to agree how best to implement nursing activities
  • Resourcing study with appropriate personnel, in line with capabilities, licensure and individuals' development goals
  • Ensuring nursing team is appropriately assigned to projects, the forecast is kept updated in relevant systems and timesheets are submitted and approved on-time, to effectively manage utilization of nursing team
  • Approving operational guidelines and nursing plans for each study once developed by the assigned nurse
  • Supporting the delivery of study-specific nurse training (if required)
  • Acting as a point of escalation for nursing team, helping to resolve study specific risks or issues and ensuring cross functional leads and project managers are kept updated
  • Overseeing that nursing team comply with study protocol, applicable regulations and SOPs and that study remains on track, escalating risks to delivery on time, within budget and to expected quality standards appropriately
  • Periodically reviewing participant and investigator feedback surveys and driving necessary changes and improvements to nursing activities if needed
  • Forecasting and managing study-specific budget and expenses related to nursing services in line with agreed budget
• Contributing to shaping the overall departmental vision and priorities and supporting execution as needed
• Leading Lightship's nursing team to deliver excellent care to patients, in compliance with all necessary regulatory requirements, ICH-GCP and departmental guidelines and SOPs
• Acting as the nursing SME for the build of new processes or systems including collaborating with Product Team to identify and implement technical solutions which can improve the efficiency of nurse operations, e.g., applications to improve ease of nurse scheduling or nurse-participant communications
• Developing a strategy for nurse scaling at speed and within budget to respond to evolving client needs, including proactively identifying and evaluating different options for building nursing team across key geographies
• Tracking the status of all required licenses, certifications, and any required competencies for all nursing personnel and home health vendors
• Other:
  • Contributing to shaping the overall departmental vision and priorities and supporting execution as needed
  • Participating in bids/ proposal development by providing input on study feasibility from a nursing standpoint, as well as helping sponsors/ clients understand opportunities for safely conducting visits outside of the clinic setting in a collaborative manner
  • Providing input internally to the budget development for proposed strategies based on nursing requirements and activities
  • Driving Lightship's general and study-specific continuous improvement efforts to optimize the patient and investigator experience through nursing activity
  • Acting as the nursing SME for the build of new processes or systems including collaborating with Product Team to identify and implement technical solutions which can improve the efficiency of nurse operations, e.g., applications to improve ease of nurse scheduling or nurse-participant communications
  • Providing Clinical Leadership with inputs on how best to operationalize new service lines/ capability offerings with nursing involvement e.g., Mobile Research Units (MRU)
  • Building the necessary policies, SOPs and operational guidelines required for the delivery of new services involving nursing (e.g., how to deliver participant care on an MRU)
  • Other duties as assigned
  
  
• Ensuring nursing team is appropriately assigned to projects, the forecast is kept updated in relevant systems and timesheets are submitted and approved on-time, to effectively manage utilization of nursing team
• Driving Lightship's general and study-specific continuous improvement efforts to optimize the patient and investigator experience through nursing activity
• Building the necessary policies, SOPs and operational guidelines required for the delivery of new services involving nursing (e.g., how to deliver participant care on an MRU)
• Acting as the primary day-to-day contact between Lightship and its existing vendors/ partners that support nursing activities (e.g., staffing agencies, equipment, and uniform providers etc.), to ensure service delivery is on track and any issues are resolved
• Developing the strategy and budget for day-to-day nursing operations in alignment with Clinical Leadership
• Managing, mentoring, and developing nursing staff, by providing necessary coaching and overseeing performance management to build high performing team
• Providing input internally to the budget development for proposed strategies based on nursing requirements and activities
• Approving operational guidelines and nursing plans for each study once developed by the assigned nurse

The Manager, Clinical Research Nursing Operations & Delivery has:

• Ability to develop SOPs and processes specific to the nursing function and contribute to departmental initiatives for the continued improvement of the clinical operations function
• Five (5) years of nursing experience, of which at least 2 years are within a hospital, clinic, or similar healthcare setting
• Current valid RN license
• Required knowledge, skills & abilities:
  • Ability to establish and maintain strong professional relationships both cross-functionally and externally with clients, strategic partners and vendors
  • Strong leadership and performance management skills, including coaching, mentoring and developing nursing talent
  • Ability to manage complex resourcing needs across multiple clinical studies and geographic locations
  • Ability to develop and manage project budgets related to nursing function
  • Excellent communication skills and ability to present vision and strategy for nurse operations to leadership effectively and collaborate cross-functionally
  • Ability to take initiative and work independently with limited guidance and structure, including proactively building solutions to solve current and anticipated problems (within and outside of studies)
  • Ability to develop SOPs and processes specific to the nursing function and contribute to departmental initiatives for the continued improvement of the clinical operations function
  • Ability to actively support with planning of departmental vision and evolution, as it relates to nursing
  • Proficiency in standard workplace software (e.g., MS Office) and EMR systems (e.g., EPIC, Cerner, or Meditech)
• At least two (2) years of clinical research experience
• At least two (2) years nursing supervisory experience or general people management experience
• Knowledge of nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG / EKG, administering injections, etc.)
• Excellent communication skills and ability to present vision and strategy for nurse operations to leadership effectively and collaborate cross-functionally
• Ability to develop and manage project budgets related to nursing function
• Bachelor of Nursing or another Science degree preferred, or requisite combination of education, training, and experience
• Ability to establish and maintain strong professional relationships both cross-functionally and externally with clients, strategic partners and vendors
• Strong leadership and performance management skills, including coaching, mentoring and developing nursing talent
• Knowledge of medical terminology, drug calculation skills, and clinical medicine
• Ability to actively support with planning of departmental vision and evolution, as it relates to nursing
• Ability to take initiative and work independently with limited guidance and structure, including proactively building solutions to solve current and anticipated problems (within and outside of studies)
• Proficiency in standard workplace software (e.g., MS Office) and EMR systems (e.g., EPIC, Cerner, or Meditech)
• Education and experience:
  • Current valid RN license
  • 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 nursing experience, of which at least 2 years are within a hospital, clinic, or similar healthcare setting
  • At least two (2) years of clinical research experience
  • At least two (2) years nursing supervisory experience or general people management experience
  • Bachelor of Nursing or another Science degree preferred, or requisite combination of education, training, and experience
• Ability to manage complex resourcing needs across multiple clinical studies and geographic locations

We would like to offer you:

• Great compensation
• The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade virtual-first clinical research solutions at scale
• An unmatched opportunity to grow as part of an established startup with industry veterans, high-caliber investors, and a massive market opportunity
• An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core

Generous benefits package, including:

• Monthly stipend for internet and phone expenses
• Generous paid parental leave
• Unlimited Paid Time Off (PTO), plus paid holidays and bereavement to help support work life balance.
• A home office stipend to set yourself up for success in our distributed working environment
• Top notch healthcare (medical, dental, and vision) for you and your family.
• Life insurance and More!
• A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.
• Company provided laptop, your choice of a PC or a Mac
• Short & long-term disability

The base salary range for this role is between $130,500 and $165,000+, depending on education, skills, and experience. To determine our compensation, we use a market-based approach that is geographically neutral. We believe that this demonstrates our company value of 'believing in people' – valuing the outputs and performance of each team member.

Please note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19.

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. EEO is the Law

Lightship is an E-Verify employer. Find out more here: Right to Work Poster E-Verify Participation Poster

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