CRA II

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 in clinical

studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and in-house 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.

The Clinical Research Associate II (CRA II) is responsible for independently monitoring clinical trial sites to ensure studies are conducted in accordance with 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 serves as the primary point of contact for assigned investigator sites and is responsible for site oversight, risk identification, issue management, protocol compliance, source data verification, investigational product accountability review, regulatory compliance assessment, and data quality oversight. This role contributes significantly to participant safety, trial quality, inspection readiness, and successful study execution.

This position is remote and requires the ability to work independently with limited supervision. Travel for site visits, investigator meetings, audits, and study-related activities may be required (approximately 25-50%).

The CRA II is responsible for:

• 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.

CRA II has:

• Required knowledge, skills, and abilities
• 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.

Education and experience

• 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).

Additional Preferred experience:

• 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.