Job Description

3 Vacancies:

▪️ Senior Clinical Research Associate - Midwest US - Remote

▪️ Senior Clinical Research Associate - West Coast US - Remote

▪️ Central Monitor/In-House CRA - US Remote

Position Summary

Our client are seeking a motivated and detail-oriented Clinical Research Associate (CRA) with a strong background in oncology to join our Clinical Development team. As a CRA, you will play a key role in supporting the planning, execution, and management of clinical trials, ensuring regulatory compliance, data quality, and patient safety. This role is essential in driving our mission to bring novel, life-saving cancer therapies to patients.

Key Responsibilities

Study Site Management:

• Conduct site initiation, monitoring, and closeout visits according to Good Clinical Practice (GCP) guidelines and study protocols.
• Develop strong, collaborative relationships with investigators and clinical site staff to ensure study adherence and support patient recruitment and retention efforts.
• Monitor patient data and study documentation to ensure accurate and timely reporting, resolving data discrepancies as needed.

Regulatory Compliance:

• Ensure that all clinical trials are conducted in compliance with FDA regulations, ICH-GCP guidelines, and relevant local regulations.
• Prepare for and assist with internal and external audits, including regulatory inspections.

Data Quality and Management:

• Perform source data verification and ensure timely data entry into Electronic Data Capture (EDC) systems.
• Collaborate with data management teams to resolve queries and maintain data integrity throughout the study lifecycle.

Communication and Documentation:

• Develop and maintain clinical trial documentation, including monitoring reports, visit letters, and study trackers.
• Communicate trial progress, challenges, and milestones to cross-functional teams, escalating issues as needed to ensure timely resolution.

Patient Safety and Risk Management:

• Review and report adverse events (AEs) and serious adverse events (SAEs) in accordance with
• Identify and address potential risks to study timelines, quality, and patient safety proactively.

Training and Collaboration:

• Train and mentor site personnel on study protocols, data collection methods, and regulatory requirements.
• Collaborate with cross-functional teams, including Clinical Operations, Biostatistics, Data Management, and Medical Affairs, to support clinical trial needs and initiatives.

Qualifications

Education:

• Bachelor’s degree in Life Sciences, Nursing, or a related field. Advanced degrees (e.g., Master’s or PhD) are a plus.

Experience:

• 2+ years of experience as a Clinical Research Associate, preferably within oncology clinical trials in biotech, CRO, or pharmaceutical settings.
• Knowledge of oncology therapeutic areas, clinical trial phases, and study designs (e.g., Phase I-IV, adaptive trials, biomarker-driven studies) is highly desirable.

Skills and Competencies:

• Strong understanding of FDA regulations, ICH-GCP, and other regulatory requirements related to clinical trials.
• Proficiency with EDC systems (e.g., Medidata Rave, Oracle InForm), Microsoft Office Suite, and other clinical trial management software.
• Excellent organizational, time-management, and problem-solving skills with a high level of attention to detail.
• Effective interpersonal and communication skills, with the ability to engage and support clinical sites, study team members, and leadership.

Other Requirements:

• Ability to travel up to 50%, including occasional international travel, depending on study needs.
• Valid driver’s license and reliable transportation, if required for site visits.
• Flexibility and adaptability in a fast-paced, evolving biotech environment.

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