CRA II

Lightship • Durham, NC

4d • Remote

About The Position

Lightship is a virtual-first provider dedicated to perfecting clinical trial processes. The Clinical Research Associate II (CRA II) is responsible for independently monitoring clinical trial sites to ensure studies adhere to approved protocols, International Council for Harmonisation Good Clinical Practice (ICH-GCP), applicable regulatory requirements, sponsor expectations, and Lightship Standard Operating Procedures (SOPs). The CRA II acts as the primary liaison for assigned investigator sites, overseeing site operations, identifying risks, managing issues, ensuring protocol compliance, verifying source data, reviewing investigational product accountability, assessing regulatory compliance, and monitoring data quality. This role is crucial for participant safety, trial quality, inspection readiness, and successful study execution. The position is remote, requiring independent work with minimal supervision. Travel for site visits, investigator meetings, audits, and study-related activities is expected (approximately 25-50%).

Requirements

• Strong knowledge of ICH-GCP, FDA regulations, and clinical trial management principles.
• Strong understanding of risk-based monitoring methodologies.
• Knowledge of decentralized, hybrid, and traditional clinical trial models.
• Strong understanding of source documentation standards and ALCOA+ principles.
• Experience using Electronic Data Capture (EDC) systems and clinical trial technologies.
• Excellent organizational, analytical, and problem-solving skills.
• Strong written and verbal communication skills.
• Ability to independently manage multiple sites and studies simultaneously.
• Ability to assess study risk and make sound compliance-based decisions.
• Ability to effectively collaborate with cross-functional teams and external stakeholders.
• Proficiency in Microsoft Office applications and applicable clinical systems.
• Bachelor's degree in Life Sciences, Nursing, Health Sciences, Clinical Research, or related field.
• Minimum 4 years of clinical research experience.
• Minimum 2-4 years of independent monitoring experience.
• Experience leading monitoring activities across multiple clinical trial sites.
• Experience conducting Site Qualification, Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Closeout Visits (COVs).

Nice To Haves

• ACRP Certified Clinical Research Associate (CCRA) certification preferred.
• SOCRA CCRP certification preferred.
• Experience monitoring Phase I-IV clinical trials.
• Experience within CRO, Sponsor, Site Network, or DCT environments.
• Experience with decentralized clinical trials (DCTs) and remote monitoring technologies.

Responsibilities

• Perform Source Data Verification (SDV) and Source Data Review (SDR) activities to ensure accuracy, completeness, consistency, and traceability of clinical data at either 100% or risk-based.
• Review electronic case report forms (eCRFs), source documentation, study records, and essential documents.
• Identify data trends, missing data, discrepancies, protocol deviations, and quality concerns.
• Collaborate with study teams and site personnel to resolve queries and data issues in a timely manner.
• Ensure compliance with ALCOA+ principles and data integrity requirements.
• Proactively identify site-level risks and quality concerns that may impact participant safety, protocol compliance, or data integrity.
• Implement corrective actions and follow-up activities to mitigate identified risks.
• Escalate significant compliance, quality, safety, or operational issues to study leadership as appropriate.
• Support CAPA development, implementation, and effectiveness verification as needed.
• Develop, execute, and maintain study-specific monitoring plans.
• Prepare detailed monitoring visit reports and follow-up correspondence within established timelines.
• Maintain regular communication with investigators, study coordinators, sponsors, vendors, and internal study teams.
• Build effective collaborative relationships with investigative sites to enhance site engagement, enrollment, and performance.
• Participate in study team meetings, investigator meetings, and cross-functional operational discussions.
• Maintain current knowledge of evolving clinical research regulations, guidance documents, and industry best practices.
• Additional Responsibilities as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level