Clinical Research Associate – Oncology

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• The position is responsible for ensuring performance and compliance for designated protocols and sites within a specific country.

• Under the supervision of the CRA-Manager, the individual guarantees adherence to study conduct in accordance with ICH/GCP, national regulations, as well as our Company's policies and procedures, quality benchmarks, and requirements for adverse event reporting both internally and externally.

• Serves as the primary contact and site manager throughout all stages of a clinical research study, assuming overall responsibility for assigned sites.

• Proactively develops and broadens the territory for clinical research by identifying and cultivating new sites.

• Engages in internal meetings and workstreams as a Subject Matter Expert (SME) for monitoring processes and systems.

• Establishes strong relationships with sites and ensures continuity of these relationships throughout all trial phases.

• Conducts clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws and regulations, the study protocol, the Site Monitoring Plan, and related documents.

• Acquires a comprehensive understanding of the study protocol and associated procedures.

• Coordinates and manages various tasks in partnership with other sponsor roles to ensure Site Readiness.

• Participates and provides input on site selection and validation processes.

• Undertakes remote and on-site monitoring and oversight activities utilizing various tools to ensure: data generated at the site is complete, accurate, and unbiased, and that the rights, safety, and well-being of subjects are safeguarded.

• Conducts site visits, including but not limited to validation, initiation, monitoring, and close-out visits, while accurately recording clear and comprehensive visit and non-visit contact reports in a timely manner.

• Collects, reviews, and monitors necessary regulatory documentation for study initiation, maintenance, and closure.

• Communicates with investigators and site staff regarding issues related to protocol execution, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.

• Identifies, evaluates, and resolves site performance, quality, or compliance issues, escalating them as necessary per the CRA Escalation Pathway in collaboration with the CRA-Manager, CRM, TA Head, and CRD when needed.

• Collaborates with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, as well as HQ functional areas and external vendors, IRB/IECs, and Regulatory Authorities to support assigned sites.

• Manages and maintains information and documentation in CTMS, eTMF, and various other systems as required and within specified timelines.

• Contributes to CRA team knowledge by serving as a process Subject Matter Expert (SME), acting as a buddy/mentor, and sharing best practices as needed.

• Supports and/or leads audit and inspection activities as necessary.

• Conducts co-monitoring visits when appropriate.

• In alignment with the country strategy defined by CRD and/or CRA-Manager, aids in identifying new potential sites and collaborates closely with them to enhance clinical research capabilities.

⛳️ Requirements

• Associate's degree, certificate, or equivalent in a scientific or healthcare discipline, accompanied by at least 5 years of relevant experience in healthcare, including a minimum of 2 years of direct site management (monitoring) experience in a bio/pharma/CRO setting.

• Alternatively, a Bachelor’s degree (or higher) with at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO environment.

• Proficient in local languages and English (both verbal and written) with exceptional communication skills, including the ability to comprehend and convey technical information effectively.

• Strong understanding and practical knowledge of clinical research, the phases of clinical trials, and current GCP/ICH and national clinical research laws and guidelines.

• Sound understanding of Global, Country/Regional Clinical Research Guidelines and the ability to operate within these frameworks.

• Practical knowledge of Good Documentation Practices.

• Demonstrated skills in Site Management, including overseeing site performance and patient recruitment.

• Proven high-level monitoring abilities with independent professional judgment.

• Competent IT skills (proficient in MS Office, various clinical IT applications on computers, tablets, and mobile devices) and the capacity to adapt to new IT applications across different devices.

• Ability to comprehend and analyze data/metrics, taking appropriate action.

• Capable of managing complex challenges and adopting a solution-oriented approach.

• Conducts root cause analysis and implements preventative and corrective actions.

🏝️ Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate and sick leave days.