Clinical Research Coordinator BMTWe are seeking a Clinical Research professional to independently coordinate and manage clinical research activities, with a focus on oncology treatment trials, including Phase I studies. The ideal candidate will have hands-on experience working in a healthcare/academic institution and using EPIC.
Required Qualifications:
Bachelor's degree in a related field and 2+ years of clinical research experience, or equivalent education and experience.
Hands-on experience with oncology treatment trials, particularly Phase I.EPIC experience.
Clinical research experience within a hospital, academic medical center, or healthcare institution.
CRO/Pharma CRA experience alone will not meet the site-based requirement.
Knowledge of FDA regulations, IRB requirements, HIPAA, and Good Clinical Practice.
Knowledge of medical terminology.
Strong interpersonal, organizational, and communication skills.
Proficiency with MS Office and research/database applications.
Responsibilities:
Independently coordinate key aspects of oncology clinical trials, including patient recruitment, enrollment, study visits, and retention.
Manage clinical research data, study documentation, milestones, and reporting.
Ensure compliance with study protocols, FDA regulations, HIPAA, and IRB requirements.
Coordinate IRB submissions and renewals and support IND-related activities when applicable.
Monitor and report adverse events/serious adverse events (SAEs) and resolve study queries.
Collaborate with Principal Investigators, sponsors, clinical teams, and research staff.
Support study budgets, milestone tracking, sponsor invoicing, and financial documentation.
Conduct compliance reviews/audits and support corrective actions and process improvements.
Lead study meetings and train/mentor research staff as assigned.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable.
