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.

Clinical Study Coordinator is an energetic, independent, and compassionate individual. This is a specialized role in clinical research that includes working with and under oversight from 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.  

Clinical Study Coordinator collects study data, completes, and maintains source documents, and performs other day-to-day activities related to study conduct, working hand in hand with either a Senior Clinical Study Coordinator or Clinical Project Manager, as appropriate. This individual will also 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.  

Additionally, this position may require travel up to 50%.

This is a 9-month contract opportunity based Towson, Maryland.

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