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Oncology Auditing Research Visionary Innovation Checklists Registration Microsoft Excel Clinical Trials Medical Records Data Collection Informed Consent Clinical Research Case Report Forms Multicenter Trial Human Subject Research Artificial Intelligence Clinical Trial Protocols Engineering Design Process Medical History Documentation Good Clinical Practices (GCP) Clinical Research Coordination Institutional Review Board (IRB), * Coordinate the initiation and activation of new clinical trial protocols, ensuring all required approvals are in place before study activation, including Scientific Review Board, Institutional Review Board, Human Research Oversight Committee, data collection plans, and finance/contract approvals.

• Prepare and organize study tools such as study binders, medication diaries, eligibility checklists, calendars, and flow sheets as required for each protocol.
• Use Oncore, Excel, and Word to develop and maintain study tools, including eligibility checklists, medication diaries, calendars, and flow sheets tailored to specific trials.
• In collaboration with the Research Nurse Clinician and/or physician, review patients' charts and medical histories to confirm protocol eligibility and obtain necessary source documents from the medical record.
• Under the direction of the Research Nurse Clinician and/or physician, ensure that the IRB-approved informed consent form is properly obtained, signed, filed in the medical record, and that a copy is provided to the patient.
• Register consented research patients with the appropriate study sponsors, including industry partners and cooperative groups, and enter all required information into the Oncore clinical trials database.
• Maintain complete and accurate research records for all enrolled patients, including consent forms, eligibility documentation, case report forms, registration confirmations, and corresponding source documents across multiple clinical locations.
• Support and coordinate patient screening, recruitment, and enrollment activities for assigned clinical trials, ensuring adherence to protocol-specific inclusion and exclusion criteria.
• Assist, in collaboration with the Research Nurse Clinician and physician, with grading adverse events using the most recent National Cancer Institute common toxicity criteria or protocol-specific grading scales.
• Complete Serious/Unexpected Adverse Event forms for internal and multicenter serious or unexpected adverse events in accordance with study sponsor requirements, federal regulations, and institutional guidelines.
• Ensure that all research records remain up to date and audit-ready for all patients enrolled on clinical trials, including those at main centers, community physician offices, and affiliated hospitals.
• Generate and provide regular reports from Oncore to tumor study group members and Principal Investigators on the status of assigned studies and enrolled subjects.
• Serve as a primary liaison with study sponsors, schedule monitoring visits and conference calls, and provide accurate and timely responses to sponsor queries.
• Understand and anticipate the needs of study sponsors to facilitate efficient study conduct and strong collaborative relationships.
• In collaboration with the Research Nurse Clinician, help ensure that all personnel involved in the study, including investigators, conduct the trial in accordance with the protocol, Good Clinical Practice guidelines, and institutional policies.
• Communicate clearly and professionally with patients, clinical teams, and study stakeholders to support patient understanding, adherence, and a positive trial experience., Union Beach, NJ*On-Site Research Chemistry Visionary Innovation Collections Scale (Map) Food Science Distillation Wet Chemistry Detail Oriented Beverage Products Technical Management Laboratory Equipment Artificial Intelligence Engineering Design Process Good Laboratory Practice (GLP) Gas Chromatography Mass Spectrometry

• Minimum 3 years of relevant clinical research experience, preferably in a clinical research coordinator or similar role.
• Hands-on experience with clinical research coordination, including patient screening, recruitment, and enrollment.
• Experience working in oncology clinical research or strong interest in oncology trials.
• Proficiency with computer software programs such as Excel and Word, with the ability to create and manage study tools and reports.
• Bachelor's degree required.
• Familiarity with Good Clinical Practice guidelines and regulatory requirements governing clinical trials., Data Analysis Data Security Detail Oriented Microsoft Excel Risk Management Compliance Risk Microsoft Office Ad Hoc Reporting Data Warehousing Analytical Skills Quality Assurance Loan Documentation Workflow Management Microsoft PowerPoint Credit Risk Management Business Administration Web Application Security Document Management Systems Standard Operating Procedure Ethical Standards And Conduct Customer Relationship Management +0, Auditing Coaching Teamwork Aviation Budgeting Mechanics Scheduling Operations Management Cleanliness Communication Team Oriented Accountability Diesel Engines Cooling Systems Health Advocacy Customer Service Safety Standards Computer Literacy Workflow Management Operation Maintenance Artificial Intelligence Discounts And Allowances Authorization (Computing) Employee Assistance Programs Key Performance Indicators (KPIs) Commercial Driver's License (CDL) Automotive Service Excellence (ASE) Certification Security Identification Display Area (SIDA) Badge +0

This is a Contract position based out of Newark, NJ. Pay and Benefits

The pay range for this position is $32.00 - $37.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type

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