Research Data Coordinator

at  RWJBarnabas Health

JOB OVERVIEW:

Research Coordinator for a Dynamic and Expanding Outpatient Oncology Research Department. The position entails managing research activities within a bustling outpatient oncology research department.

QUALIFICATIONS:

Required:

• Bachelor s Degree in a related field
• Strong interpersonal and communication skills are required.
• Must be self-motivated and able to multitask on a variety of projects

Preferred:

• Clinical Research experience

SCHEDULING REQUIREMENTS:

• Day Shift
• Mon- Fri Schedule
• Full-Time

ESSENTIAL FUNCTIONS:

• Responsible for coordinating clinical trials, including study initiation, collection of clinical data, and management of data entry
• Using OnCore, Excel, and Word, creates study tools such as eligibility checklists, medication diaries, calendars, and flow sheets, as required
• Collaborates with the Research Nurse Clinician and/or physician to review patient charts and medical history, confirming protocol eligibility and obtaining necessary source documents
• Ensures IRB-approved informed consent is obtained, signed, placed in the medical record, and provided to the patient under the direction of the RNC and/or physician
• Registers consented research patients with study sponsors and input data into the OnCore clinical trials’ database managed by the Cancer Institute of New Jersey and RWJUH Somerset
• Scheduling patient appointments, coordinating clinical assessments and patient care for study participants, liaising with ancillary departments within the Cancer Institute per protocol requirements
• Maintains comprehensive research records for all patients enrolled in Cancer Institute of New Jersey and RWJUH Somerset clinical trials
• Assists in grading adverse events and completes Serious/Unexpected Adverse Event forms as required by study sponsors and regulatory guidelines
• Enters data into auditable databases or electronic data capture systems, ensuring accuracy and addressing queries from monitors
• Provides regular reports to Disease Specific Group members and Principal Investigator using OnCore
• Acts as a liaison with study sponsors, scheduling monitoring visits and conference calls, and providing timely responses to queries
• Ensures adherence to treatment plans and Good Clinical Practice guidelines by Cancer Institute and RWJUH Somerset personnel, including investigators
• Participates in ongoing quality assurance activities and communicates effectively with staff and outside agencies to promote teamwork
• Collaborates with Biorepository Services to meet study-specific deadlines for sample submission and obtain specialized reports as needed
• Adheres to policies and procedures set forth by RBHS, Cancer Institute of New Jersey, RWJUH Somerset, FDA, and regulatory bodies
• Maintains trial regulatory binders and ensures compliance with Institutional, State, and Federal regulations throughout the research project
• Ensures research protocols are approved by the Institutional Review Board and followed as written

OTHER DUTIES:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.