Clinical Research Coordinator II

at Loyola University Of Chicago in Maywood, Illinois, United States

Job Description

Position Details

Position Details
Job Title 
 CLINICAL RESEARCH COORDINATOR II
Position Number 
 8150286
Job Category 
 University Staff
Job Type 
 Full-Time
FLSA Status 
 Non-Exempt
Campus 
 Maywood-Health Sciences Campus
Department Name 
 CBCC Research
Location Code 
 CBCC RESEARCH (06310A)
Is this split and/or fully grant funded?  
 Yes
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.
Minimum Education and/or Work Experience 
 Bachelors Degree OR equivalent training acquired via work experience or education
2-5 years of previous job-related experience
Qualifications 
 - Ability to follow verbal 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... For full info follow application link.

Loyola University Chicago is an Equal Opportunity / Affirmative Action employer with a strong commitment to hiring for our mission and diversifying our faculty and staff. All qualified applicants will receive consideration for employment without regard to race, color, religion (except where religion is a bona fide occupational qualification for the job), national origin, sex, age, disability, marital status, sexual orientation, gender identity, protected veteran status or any other factor protected by law.

Loyola University Chicago is an Equal Opportunity Employer.