Job Description
Position Details
Position Details
Job Title CLINICAL RESEARCH COORDINATOR II
Position Number [click to reveal phone number]8150661
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 Duties and 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.
- 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.
- Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
- Participate in monitor visits and regulatory audits.
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
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
Minimum Education and/or Work Experience - Bachelors Degree OR equivalent training acquired via work experience or education
- Less than one year of previous job-related experience
Qualifications - Experience with oncology population preferred.
- Project management skills.
- Excellent written and verbal communication skills.
- Experience working in clinical trials highly desirable.
- Bachelors Degree OR equivalent training acquired via work experience or education
- Less than one year of previous job-related experience
Certificates/Credentials/Licenses - SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire
Computer Skills - Computer literacy with word processing, Excel, internet, databases, electronic data capture.
Supervisory Responsibilities No
Required operation of university owned vehicles No
Does this position require direct animal or patient contact? No
Physical Demands Repetitive Motions
Working Conditions Irregular Hours
Open Date Close Date Position Maximum Salary or Hourly Rate $31.25/hr
Position Minimum Salary or Hourly Rate $22.60/hr
Special Instructions to Applicants 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 at . For information about the university's focus on transformative education, they should consult our website at .
About Loyola University Chicago Founded in 1870, Loyola University Chicago is one of the nation's largest Jesuit, Catholic universities, recognized for its academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola leverages its status as one of an elite group of universities with the highest level of research activity to advance knowledge that serves communities and creates global impact. With
15 schools, colleges, and institutes -including Business, Law, Medicine, Nursing, and Health Sciences-Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy, that provide students a transformative, globally connected learning experience. Consistently ranked among the nation's top universities by U.S. News & World Report, Loyola is a STARS Gold-rated institution that is ranked as one of the country's most sustainable campuses by The Princeton Review and has earned distinctions from AmeriCorps and the Carnegie Foundation for its longstanding record of service and community engagement. Guided by its Jesuit mission and commitment to caring for the whole person, Loyola educates ethical leaders who think critically, act with purpose, and strive to create a more just and sustainable world.
Loyola University Chicago strives to be an employer of choice by offering its staff and faculty a wide array of affordable, comprehensive, and competitive benefits. To view our benefits in detail,
click here .
Loyola adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University's
Nondiscrimination Policy .
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