Senior Clinical Research Coordinator - Oncology
Vitalief Inc. · Newark, NJ · 2 wk ago
Analyst$75k–$85k/yrFull-time
Responsibilities
- Support the execution of Phase II–IV oncology clinical trials, including pharmaceutical-sponsored, ECOG, and investigator-initiated studies.
- Manage trials across multiple oncology disease groups, including GYN, Breast, GI/GU, Head & Neck, and Lung cancers.
- Oversee a portfolio of approximately 15–20 active clinical trials in a fast-paced, high-volume clinical environment.
- Identify and screen potential study participants using physician schedules, pathology reports, multidisciplinary tumor boards, referrals, and other clinical resources.
- Obtain informed consent and enroll eligible patients in accordance with protocol requirements and regulatory standards.
- Manage patients throughout the clinical trial lifecycle, from consent through completion of active treatment.
- Educate patients regarding study procedures, treatment schedules, and protocol requirements.
- Coincide patient care activities with physicians, infusion teams, nursing staff, radiology, pathology, laboratories, and other clinical departments.
- Maintain accurate clinical trial documentation, source records, regulatory files, patient calendars, and study-related documentation.
- Ensure compliance with study protocols, Good Clinical Practice (GCP), institutional policies, and regulatory requirements.
- Provide guidance and mentorship to junior CRC team members and support team collaboration.
Qualifications
- Bachelor’s degree in health science, life science, nursing, or a related field.
- Minimum of 3 years of clinical research coordination experience supporting interventional Phase II–IV clinical trials.
- Required oncology clinical trial experience, preferably with exposure to multiple oncology disease areas.
- Experience with patient identification, pre-screening, informed consent, enrollment, retention, regulatory compliance, and clinical data management.
- Prior experience mentoring or supporting the development of junior CRCs.
- Proficiency with EPIC and OnCore™ CTMS.
- Ability to manage multiple concurrent studies while maintaining strong attention to detail and organization.
- Adaptable, solutions-oriented mindset with the ability to work effectively in a small, collaborative team environment.
- Strong interpersonal and communication skills with the ability to work closely with physicians, nurses, research staff, hospital departments, and external partners.
- Experience ensuring SAEs are documented, completed, and reported within protocol-defined timelines.
- Proficiency with Microsoft Office applications and clinical research systems.