Mobile Research Unit Clinical Study Coordinator (Contract)

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 inhouse 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.

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 study activities, 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 a 9-month contract opportunity based in College Park, Maryland that will require travel up to 90% to conduct studies on our Mobile Research Unit.

The MRU (Mobile Research Unit) Clinical Study Coordinator is responsible for:

• 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
  • 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
  • Collecting and transporting IP as needed
  • Completing sample processing as needed
  • Assisting 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
• 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 and conduct data entry, 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.
• 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 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
  • Assisting patients, investigators, and study personnel in troubleshooting problems with supplies, equipment, or vendors
  • Other study-related activities as assigned

The MRU (Mobile Research Unit) 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 p