Clinical Research Coordinator II; IITs

Position Details

Job Title:

CLINICAL RESEARCH COORDINATOR II

Position Number: 8150814

Job Category:
University Staff

Job Type: Full-Time

FLSA Status:
Non-Exempt

Campus:
Maywood-Health Sciences Campus

Department Name: RADIATION ONCOLOGY

Location Code: RADIATION ONCOLOGY (06720A)

Is this split and/or fully grant funded? Yes

• Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines.
• Serve as Primary Contact with Research Participants, Sponsors, and Regulatory agencies.
• Coordinate multi-site studies from startup through close-out. Facilitate and manage communication between Study sites, and communication with the Coordinating Center.
• In collaboration with the Principal Investigator (PI) and Manager, will develop Study operations manual, data collections forms, case reports and other source documents for Investigator initiated Studies.
• In collaboration with the PI & RN, incorporates clinical judgment and knowledge of protocol to identify potential Study participants according to inclusion and exclusion criteria.
• Coordinate collection of Study specimens and processing.
• Collect and manage Patient and Laboratory data for Clinical Research Projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with Sponsors, acting as Primary Contact.
• Ensure adherence to Study budgets and resolve billing issues in collaboration with finance and/or management Staff.
• Interact with the Principal Investigator regularly, ensuring Patient safety and adherence to proper Study conduct.
• Ensure essential documentation and recording of Patient and Research data in appropriate files per institutional and regulatory requirements.
• Participate in Monitor visits and regulatory audits.

• Processes local IRB submissions to include new Research projects, amendments, adverse events and Study terminations.
• Other duties as assigned.

• Bachelors Degree OR equivalent training acquired via work experience or education.
• 2 – 5 years of previous job-related experience.
• SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire.

• Ability to follow oral and written instructions and established procedures.
• Ability to perform basic filing, office procedures and word processing.
• Ability to maintain accuracy and consistency.
• Ability to communicate verbally.
• Ability to finish tasks in a timely manner.
• Ability to maintain confidentiality.
• Ability to compose letters and memorandums.
• Ability to deal calmly and courteously with people.
• Ability to analyze and interpret data.
• Ability to function independently and manage own time and work tasks.
• Ability to work as an effective Team member.
• Ability to organize workflow.
• Ability to negotiate, persuade and establish direction.
• Ability to maintain office files and follow standard office procedures.
• Skilled job requiring high level of adaptability & interpersonal skills.
• Ability to interact with internal and external constituents.

• CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) is required.

• Proficiency with Microsoft Word, Groupwise, EPIC, Microsoft Excel, Basic Keyboarding Skills, Adobe Acrobat, Beacon.
• Clinical Trials Management System.
• Electronic data entry web based data bases.

Supervisory Responsibilities:

No

Required operation of university owned vehicles:
No

Does this position require direct animal or patient contact? Yes

Physical Demands:
None

Working Conditions:

None

Open Date: 11/10/2025

Position Maximum Salary or Hourly Rate: $30/hr

Position Minimum Salary or Hourly Rate:…