Clinical Research Nurse Coordinator

Overview

Lightship is the virtual-first provider that is perfecting the way clinical trials get done. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence to clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and in-house 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.

The Clinical Research Nurse is an energetic, independent, and compassionate individual. This is a specialized role in clinical research works directly with patients in our studies under oversight of study investigators and clinical study lead to perform delegated clinical research activities.

The Clinical Research Nurse works in a pivotal role ensuring the delivery of quality nursing care to patients in their homes or in our Mobile Research Unit (MRU). This individual will ensure 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 patients. When study visits or procedures take place in patients' homes or on the MRU, the Clinical Research Nurse will make visits to complete these procedures.

The Clinical Research Nurse is also responsible for coordinating communication and activities among patients, investigators, primary healthcare provider, vendors, and other study personnel to prepare for and complete remote (via telemedicine) study visits, procedures, assessments, and other day-to-day activities related to study conduct.

Clinical Research Nurse will work with various Lightship business units as needed to develop and implement standard research processes to successfully complete technology-enabled Direct-to-Patient (DtP) clinical research.

A successful candidate will possess a willingness and desire to work independently without significant supervision. Lightship expects each individual to anchor their availability in the standard operating hours for their geographic location, however, true to our values of inclusion and flexibility, this role, along with all others at Lightship, may be asked to flex work hours to accommodate US West Coast, US East Coast, and UK-based time zones, based on business need. In practice, this may translate to days that have a slightly earlier start or evenings that have a slightly later end. Culturally, we aim to balance the ability to operate across time zones with respect for each individual's daily life.

This is position is required to maintain an in-person with our Richmond, VA sites and partners. A successful candidate will possess a willingness and desire to work independently without significant supervision. Additionally, this position may require practitioner to travel to the patients' homes

The Clinical Research Nurse Coordinator is responsible for:

• Managing patients' reimbursement payments per protocol and as specified in the consent form
• Ordering study supplies, materials, and equipment
• Other study-related activities as assigned
• Documenting study data in patient records (paper and electronic, as applicable) to capture protocol requirements
• Completing pre-screening activities (e.g., phone screening) and other recruitment activities as approved by the IRB
• Providing nursing care to study patients, which includes:
  • Completing study visits with patients in their home and/or on the Mobile Research Unit (MRU) per protocol requirements and adhering to relevant federal, state, and local research regulations
  • Ensuring compliance with each study's protocol by providing thorough review and documentation at each patient visit
  • Performing protocol defined procedures and assessments, including, but not limited to, vital signs, physical examinations, and electrocardiograms
  • Administering investigational medications or providing patient education regarding administration, as necessary
  • Notifying Principle Investigator of findings / issues / possible adverse events identified during the study visits
  • Educating patients on study procedures; responding to patients' questions in a compassionate and cultural / age-appropriate manner; triaging patients' questions to the appropriate study personnel
  • Documenting study data in patient records (paper and electronic, as applicable) to capture protocol requirements
• Ensuring compliance with each study's protocol by providing thorough review and documentation at each patient visit
• Participating in site qualification, initiation, and monitoring visits, as requested; assisting with external and internal audits, as requested
• Successfully completing all Lightship and study-specific training; training peers as requested
• Notifying Principle Investigator of findings / issues / possible adverse events identified during the study visits
• Assisting with resolving budget questions related to patients' activities
• Alerting investigator / sub-investigator / designated personnel when patients report potential adverse events
• Coordinating general study activities, including:
  • Assisting with study start-up and close out activities
  • Ordering study supplies, materials, and equipment
  • Assisting patients, investigators, and study personnel in troubleshooting problems with supplies, equipment, or vendors
  • Successfully completing all Lightship and study-specific training; training peers as requested
  • Coordinating and scheduling meetings as requested, including preparing meeting agendas, keeping minutes, and distributing minutes to relevant parties
  • Participating in site qualification, initiation, and monitoring visits, as requested; assisting with external and internal audits, as requested
  • Assisting with resolving budget questions related to patients' activities
  • Other study-related activities as assigned
• Coordinating and conducting study activities with patients and serving as the primary point of contact for patients, investigators, and study personnel, including:
  • Completing pre-screening activities (e.g., phone screening) and other recruitment activities as approved by the IRB
  • Participating in recruitment and selection of study patients by interviewing and documenting medical history / medication history per protocol requirements
  • Coordinating research procedures and assessments; keeping track of all planned and completed study visits
  • Organizing patients', investigators', home health personnel, and any relevant vendors' (e.g., drug management vendor) schedules to complete study visits within protocol windows
  • Shipping materials to patients or home health personnel in preparation for study visits; collecting study materials after visits are completed
  • Assisting investigator / sub-investigator / designated personnel in the informed consent process as requested and delegated
  • Alerting investigator / sub-investigator / designated personnel when patients report potential adverse events
  • Managing patients' reimbursement payments per protocol and as specified in the consent form
• Assisting investigator / sub-investigator / designated personnel in the informed consent process as requested and delegated
• Administering investigational medications or providing patient education regarding administration, as necessary
• Organizing patients', investigators', home health personnel, and any relevant vendors' (e.g., drug management vendor) schedules to complete study visits within protocol windows
• Educating patients on study procedures; responding to patients' questions in a compassionate and cultural / age-appropriate manner; triaging patients' questions to the appropriate study personnel
• Coordinating and scheduling meetings as requested, including preparing meeting agendas, keeping minutes, and distributing minutes to relevant parties
• Coordinating research procedures and assessments; keeping track of all planned and completed study visits
• Performing protocol defined procedures and assessments, including, but not limited to, vital signs, physical examinations, and electrocardiograms
• Shipping materials to patients or home health personnel in preparation for study visits; collecting study materials after visits are completed
• Assisting with study start-up and close out activities
• Completing study visits with patients in their home and/or on the Mobile Research Unit (MRU) per protocol requirements and adhering to relevant federal, state, and local research regulations
• Participating in recruitment and selection of study patients by interviewing and documenting medical history / medication history per protocol requirements
• Assisting investigators, sub-investigators, and other Lightship personnel in successful implementation and conduct of research studies
• Assisting patients, investigators, and study personnel in troubleshooting problems with supplies, equipment, or vendors

The Clinical Research Nurse Coordinator has:

• 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
• Exceptional ability to work as part of a team and to multitask effectively
• Ability to self-monitor the collected data and resolving / correcting errors per Good Documentation Practices
• Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
• Ability to function independently in a technology-enabled clinical research setting
• Strong communication skills, including verbal, written, and presentational
• Calm and collected manner when working with patients, physicians, and other research professionals
• Required knowledge, skills, and abilities

• Two (2) years of experience administering vaccinations
• Valid driver's license
• Two (2) years of recent clinical nursing experience in a hospital, clinic, or similar health care setting
• Minimum of a diploma from an accredited nursing school, required
• Two (2) years of sponsored clinical research experience
• Knowledge of nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG / EKG, administering injections, etc.)
• Education and experience
  • Multi-state license preferred
• Current valid RN license
• Bachelor of Nursing or another Science degree preferred, or requisite combination of education, training, and experience
• Personal vehicle for on-the-job transportation
• Knowledge of medical terminology, drug calculation skills, and clinical medicine
• Multi-state license preferred

We would like to offer you:

• 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
• Great compensation

Generous benefits package, including:

• Top notch healthcare (medical, dental, and vision) for you and your family.
• Company provided laptop, your choice of a PC or a Mac
• A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.
• Short & long-term disability
• Monthly stipend for internet and phone expenses
• Life insurance and More!

The base salary range for this role is between $50-65/hr+, 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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