Clinical Study Coordinator

Overview

Lightship is a clinical trials service provider leading in increasing access and choice in taking part in research to improve equity for all. We design and conduct studies in partnership with biopharmaceutical companies to accelerate bringing new therapies to market. Our approach is to engage people where they are and support them across their journey in a clinical trial, from first contact to study completion. We work to make it easy, convenient, and safe for people to take part by offering visits in clinic, at home, using our mobile research units, and digital health tools. By transforming the way, we conduct clinical research, we can decrease study timelines and reduce dropouts to accelerate development of better therapies.

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.  

Additionally, this position will require moderate travel, approximately 50% in various locations from Winston Salem, NC to Hickory, NC.

The Clinical Study Coordinator is responsible for:

• Assisting investigators, sub-investigators, and other Lightship personnel in successful implementation and conduct of research studies
• Understanding and complying with all regulations, policies, and guidelines applicable to clinical research, including GCP, FDA, and IRB requirements
• Adhering to study protocol and performing the assigned study tasks per delegation
• Tracking and reporting status of key study activities and milestones to study team (as requested)
• Preparing, reviewing, and maintaining essential regulatory documents, ensuring that required essential documents are accurate, complete and current and are filed in the ISF, as assigned  
• Facilitating site staff training and access to applicable systems
• Preparing and distributing study reports (e.g., screening, enrollment, AEs, deviations) as requested
• Supporting process improvement initiatives, as they relate to study coordination, through the building of SOPs, working instructions, process flows etc.
• Assisting with Institutional Review board (IRB) submissions or addressing IRB correspondence, as requested
• Coordinating and conducting study activities with patients and serving as the primary point of contact for patients, investigators, and study personnel, including but not limited to:
  
  • Patient scheduling
  • Pre-screening activities (e.g., phone screening) and other recruitment activities as approved by the IRB
  • Addressing patients’ questions about research studies
  • Collecting preliminary medical history from patients
  • Collecting and reviewing medical records from patients’ providers
  • 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 patients, investigators, home health personnel, and any relevant vendors to prepare for, complete, and follow up on study visits
  • 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 and ensuring proper documentation and follow-up of such events
  • 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
  • Managing patients’ reimbursement payments per protocol and as specified in the consent form
• Maintaining meticulous accuracy in completing all study documentation (paper and electronic) and ensuring that ALCOA-C standards are upheld, including:
  • Completing and maintaining source documentation
  • Collecting study data and completing data entry / case report forms in various electronic systems and on paper
  • Assisting in developing source forms, case report forms, and other study materials (paper and electronic)
  • Participating in user acceptance testing activities related to electronic source documentation, case report forms, other electronic study materials
  • Assisting in setting up and maintaining study website / landing page
  • Assisting investigators, study managers, and other personnel in internal study monitoring activities
  • Assisting in record retention activities after study is completed
  • Addressing data queries and completing data corrections per Good Documentation Practices
• 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
  • 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
  • Driving the Mobile Research Unit (MRU) to designated, various locations from San Diego, CA to Los Angeles, CA after successful completion of MMM training
  • Other study-related activities as assigned 

The Clinical Study Coordinator has:

• Required knowledge, skills, and abilities
  • Strong communication skills, including verbal, written, and presentational
  • Effective problem-solving skills
  • Calm, collected and compassionate demeanor when working with patients, and their caregivers or family members
  • Ability to build rapport with investigators and site staff to establish effective working relationship, necessary for excellence in project delivery
  • High level of self-motivation with a willingness to proactively address gaps and drive improvements
  • Exceptional ability to work as part of a team and to multitask effectively
  • Ability to function independently in a technology-enabled clinical research setting
  • Self-monitoring capability to review, resolve and correct collected data as needed
  • Good Documentation Practices
  • Aptitude to update systems in a timely and accurate way
  • Ability to be highly organized in an environment with shifting priorities
  • Flexibility to travel if requested
    
• Education and experience
  • Bachelor’s Degree in Life Science or healthcare-related field, or requisite combination of education, training, and experience
  • At least two (2) years of sponsored clinical research experience, required
  • Bilingual in English and Spanish, preferred
  • Must have access to reliable transportation to support all events

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 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
• Great compensation

Generous benefits package, including:

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

The base salary range for this role is between $65,000 - 80,000, 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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