Overview

Lightship is the premier provider of enterprise level, technology enabled direct-to-patient clinical research solutions. We engage patients at home, making participation in clinical research more accessible for everyone.

Lightship is seeking an energetic, independent, and compassionate individual to join our team as a Clinical Study Coordinator. This is a specialized role in clinical research that includes working with and under oversight of study investigators to perform delegated clinical research activities.

Clinical Study Coordinator works in a pivotal role of coordinating communication and activities among patients, investigators, home health personnel, vendors, and other study personnel to prepare for and complete remote (via telemedicine) study visits, procedures, and assessments.   

The study coordinator will also collect study data, complete and maintain source documents, and perform other day-to-day activities related to study conduct. Clinical Study Coordinator 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.

This position is based in El Segundo, CA. A successful candidate will possess a willingness and desire to work independently without significant supervision. Additionally, this position may require moderate travel.

You will be 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
  • Coordinating / conducting study activities with patients and serving as the primary point of contact for patients, investigators, and study personnel, including:
    • 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 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’s, 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
    • 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
    • Preparing and distributing study reports (e.g. screening, enrollment, AEs, deviations) as requested
    • Maintaining essential study documents; preparing or addressing IRB correspondence, as requested
    • 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
    • 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

We are excited to speak with someone who has:

  • Required knowledge, skills, and abilities
    • Strong communication skills, including verbal, written, and presentational
    • Effective problem-solving skills
    • Calm and collected manner when working with patients, physicians, and other research professionals
    • Exceptional ability to work as part of a team and to multitask effectively
    • Ability to function independently in a technology-enabled clinical research setting
    • Ability to self-monitor the collected data and resolving / correcting errors per Good Documentation Practices
  • Education and experience
    • 2+ years of related clinical research experience, required
    • Bilingual in English and Spanish, preferred
    • Bachelor’s Degree in Life Science or healthcare-related field, preferred; ACRP or CCRC certification, preferred; or requisite combination of education, training, and experience

We would like to offer you:

  • A platform to develop your clinical research and coordinating skills in healthcare
  • An opportunity to help re-envision how clinical research is executed and deliver high-quality research outputs
  • The chance to work with a patient-centered, clinically oriented, collaborative team to deliver enterprise grade direct-to-patient clinical research solutions at scale
  • An unmatched opportunity to grow as part of an early stage startup
  • Competitive compensation including a performance bonus
  • Generous benefits package including:
    • Health, dental & vision that are effective on day one of employment
    • 401K with company match
    • Twelve-week maternity leave with 100% of salary
    • Six-week parental leave with 100% of salary
    • Short & long-term disability
    • Generous Paid Time Off (PTO), plus holidays and bereavement leave
    • Life insurance
    • Pre-tax commuter benefits
    • Fitness reimbursement
    • Employee assistance program
    • Employee discounts (retail, hotels, food, restaurants, car rentals, and much more)

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