Job Opportunity
This is a challenging position for a professional who can assess clinical study site qualifications, implement studies at participating sites, and manage site conduct.
Responsibilities
* Evaluate, initiate, monitor, and close clinical study sites.
* Ensure site conduct adheres to protocols, GCP regulations, International Harmonization Guidelines, company SOPs, and applicable regulatory requirements.
* Train/re-train site personnel on protocols, systems, and operational aspects of trials.
* Serve as primary contact for site personnel and sponsor study team members.
* Develop patient recruitment strategies with clinical sites to meet enrollment timelines.
* Protect subjects' rights, safety, and well-being.
* Ensure compliance with adverse event procedures.
* Evaluate data quality and integrity, ensuring timely resolution of queries.
* Assist Data Management in developing eCRFs and eCRF Completion Guidelines.
* Identify and resolve site performance, quality, or compliance issues.
* Communicate with Investigators, site staff, Sponsor Study Team Members, and QA on protocol conduct, subject recruitment, and overall site performance.
* Maintain audit-ready trial documentation.
* Collect, review, and file required regulatory documentation during study maintenance and closeout.
Requirements
* Bachelor's degree in Life Sciences or RN preferred.
* Minimum 5+ years of pharmaceutical/biotechnology industry experience as a Clinical Research Associate from start-up to database lock.
* Strong Oncology monitoring experience in phase 1-3 pharmaceutical/biotechnology clinical trials.
* High level of monitoring skill with independent judgment.
* Excellent understanding of ICH guidelines, GCP, PhRMA code, FDA CFR, clinical research ethics, HIPAA, and local regulatory requirements.
* Strong knowledge of clinical research concepts and drug development.
* EDC, IVRS, and CTMS system proficiency.
* Microsoft Office skills.
* Ability to work independently across multiple studies, projects, and sites.
* Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills.