Clinical Research Coordinator ; IITs

Clinical Research Coordinator I (IITs)

As a Jesuit, Catholic institution of higher education, we seek candidates who will contribute to our strategic plan to deliver a Transformative Education in the Jesuit tradition. To learn more about Loyola University Chicago's mission, candidates should consult our website .edu/mission/. For information about the university's focus on transformative education, they should consult our website .edu/transformativeed.

Job Title - CLINICAL RESEARCH COORDINATOR I

Position Number - 8150814

Work Modality
- Fully In-Person

Is this request for the creation of a new Position (or the modification of an existing Position) to temporarily support the Work Day ERP? - No

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

Duties and Responsibilities
- Coordination responsibilities

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 studies from startup through close-out. 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. Regulatory responsibilities:
Processes local IRB submissions to include new research projects, amendments, adverse events and study terminations. Performs other duties as assigned Regulatory responsibilities:
Establish and maintain research project's regulatory files Ongoing communication with the local IRB, federal organizations, affiliate institutions and pharmaceutical study sponsors. Data Management Responsibilities:
Collects, records and maintains accurate data reporting adhering to protocol data collection protocol and federal guidelines. Clarifies Data Queries.

Specimen Handling and Shipping Responsibilities:
Coordinates with the Clinical Research RN to organize procurement of research samples and then prepares, packages and ships research samples. Manages research sample supplies Participates in Cooperative Group Audits, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits. Performs related duties as assigned

Minimum Education and/or Work Experience
- Bachelor's Degree OR equivalent training acquired via work experience or education.

Qualifications
- Preferred qualifications

Experience with oncology population preferred. Project management skills. Excellent written and verbal communication skills. Experience working in clinical trials highly desirable.

Certificates/Credentials/Licenses - CCRA(Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) is desired.

Computer Skills
- Proficiency with Microsoft Word, Groupwise, EPIC, Microsoft Excel, Basic Keyboarding Skills, Adobe Acrobat, Beacon. Clinical Trials Management…