Clinical Study Coordinator
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Job Description
About Lightship:
Lightship is a virtual-first provider revolutionizing the clinical trial process. They focus on operational excellence to deliver life-enhancing and lifesaving innovations to market faster. Their end-to-end hybrid delivery model, diverse skillsets, and in-house care team prioritize sponsor success and an optimal patient experience. Operational excellence is fundamental to their approach.
Job Description: Clinical Study Coordinator
This is a 12-month contract opportunity based in the Fort Meade, Maryland area, potentially requiring up to 50% travel. The Clinical Study Coordinator is a pivotal role, coordinating communication and activities among patients, investigators, home health personnel, vendors, and other study personnel for remote (telemedicine) clinical studies. The position demands an energetic, independent, and compassionate individual with strong problem-solving skills. While standard operating hours are expected based on geographic location, flexibility is required to accommodate US West Coast, US East Coast, and UK time zones.
Responsibilities:
• Assisting in Study Implementation and Conduct: Supporting investigators and Lightship personnel in successful study execution. Adhering to all applicable regulations (GCP, FDA, IRB) and study protocols. Tracking and reporting key study activities and milestones. Preparing and maintaining regulatory documents. Facilitating site staff training and system access. Preparing and distributing study reports. Contributing to process improvements through SOP development and documentation. Assisting with IRB submissions and correspondence.
• Patient Coordination and Communication: Serving as the primary point of contact for patients, investigators, and study personnel. This includes patient scheduling, pre-screening, recruitment activities (IRB approved), collecting medical history and records, coordinating procedures and assessments, managing schedules for all involved parties, shipping and collecting study materials, assisting with informed consent, reporting adverse events, educating patients, managing patient reimbursements, and addressing patient questions compassionately and appropriately.
• Data Management and Documentation: Maintaining meticulous accuracy in all study documentation (paper and electronic), adhering to ALCOA-C standards. This includes completing and maintaining source documentation, collecting and entering study data, assisting in developing source forms and case report forms, participating in user acceptance testing, assisting in setting up and maintaining study websites, assisting in internal study monitoring, assisting in record retention, addressing data queries and corrections.
• General Study Coordination: Assisting with study start-up and close-out, troubleshooting problems with supplies/equipment/vendors, scheduling meetings, preparing agendas and minutes, participating in site visits and audits. Assisting with budget questions related to patient activities and other study-related tasks as assigned.
Required Knowledge, Skills, and Abilities:
• Strong communication skills (verbal, written, presentational)
• Effective problem-solving skills
• Calm, compassionate demeanor when interacting with patients and their families
• Ability to build rapport with investigators and site staff
• High level of self-motivation and proactive approach
• Exceptional teamwork and multitasking abilities
• Ability to work independently in a technology-enabled setting
• Self-monitoring capabilities for data review and correction
• Good Documentation Practices
• High organizational skills in a dynamic environment
• Flexibility to adjust work hours and travel as needed
Education and Experience:
• 2+ years of relevant clinical research experience required.
• Bilingual (English/Spanish) preferred.
• Bachelor’s Degree in Life Science or healthcare-related field, or equivalent combination of education, training, and experience.
Compensation and Benefits:
• Base salary range: $50,000 – $65,000 (depending on education, skills, and experience)
• Generous benefits package (healthcare, paid holidays, 401k match, stipend for internet/phone, disability, life insurance)
• Company-provided laptop
COVID-19 Vaccination Requirement: Vaccination against COVID-19 is required for this position due to patient and staff safety protocols.
