Clinical Research Coordinator II

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 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.

Certificates/Credentials/Licenses

SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire

Computer Skills

Proficient in Microsoft Office suite.

REDcap proficiency preferred

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 08/03/2023 Close Date Special Instructions to Applicants Diversity and Inclusion Statement Diversity, Equity, and Inclusion

As one of the nation's largest Jesuit, Catholic universities, Loyola University Chicago fosters a transformative cultural experience that honors diversity, equity, and inclusion. We are committed to not only recruiting, but also retaining a diverse, mission driven workforce and enabling a culture of inclusiveness in an environment that values service excellence, stewardship, personal well-being, and professional development for all of our employees. Loyola University Chicago supports its staff and faculty with a wide array of affordable, comprehensive and competitive benefits centered on health and wellness, financial security, equity, and work-life balance. We actively seek those who wish to join our faculty, staff, and students in a community of diverse opinions, perspectives, and backgrounds supporting our Jesuit mission and striving toward the same goal of being persons for and with others.