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.
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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
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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 |
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Special Instructions to Applicants |
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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.
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Quick Link for Posting |
https://www.careers.luc.edu/postings/25738 |
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