Astera Cancer Care · 23 hours ago
Clinical Research Coordinator
Astera Cancer Care is dedicated to providing excellence in patient care and research within the communities of New Jersey and Pennsylvania. As an Oncology Clinical Research Coordinator, you will manage clinical trial activities, recruit participants, and ensure compliance with regulatory standards for successful study management.
Clinical TrialsHealth CareHealth DiagnosticsHospitalOncology
Responsibilities
Provide overall coordination of study-related activities for patients enrolled in cancer research studies through the Astera research program
Coordinate with Principal Investigators, Supervisor and study sponsors and CROs to ensure that clinical research activities are performed in accordance with local and federal regulations and adhere to policies and procedures of Astera and the sponsors and CROs
Assist in the coordination of tests and visits for patients and collaborate with the Astera study team to maximize work efficiency and productivity
Assist in IRB submissions and interact with the Supervisor to maintain regulatory documents and administrative files for each protocol
Work with research nurses, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials
Maintain patient and regulatory research records
Confer with all members of the clinical team to confirm appropriateness and timeliness of tests
Collect follow-up data on patient’s post-treatment as required by the protocol
Submit weekly reports to Supervisor, tracking patient screening/enrollment and subject status
Enter research data into a centralized database as per protocol requirements
Attend investigator meetings as required or requested by the Principal Investigator
Prepare other study materials as requested by the Principal Investigator such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs
If applicable, able to prepare blinded and unblinded study drugs
If applicable, act as primary coordinators for unblinded team
Qualification
Required
A Bachelor's degree or equivalent working experience required
At least one (1) year of clinical research experience, Oncology experience a plus
Experience in Oncology Patient Recruitment and retention skills
Experience with EDC, IWRS. CRF and Microsoft applications
Able to travel between offices within the offices in Northeast Jersey area
Excellent communication skills
Excellent time management skills
Preferred
Pharmacy Technician certified with infusion drug preparation training