Position Details
Position Details
Job Title |
CLINICAL RESEARCH COORDINATOR I |
Position Number |
8150113 |
Job Category |
University Staff |
Job Type |
Full-Time |
FLSA Status |
Non-Exempt |
Campus |
Maywood-Health Sciences Campus |
Department Name |
CBCC RESEARCH |
Location Code |
HEMATOLOGY - ONCOLOGY (06508A) |
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
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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 |
- Ability to analyze and interpret data
- Ability to communicate verbally
- Ability to compose letters and memorandums
- Ability to deal calmly and courteously with people
- Ability to finish tasks in a timely manner
- Ability to follow oral and written instructions and established procedures
- Ability to function independently and manage own time and work tasks
- Ability to maintain accuracy and consistency
- Ability to maintain confidentiality
- Ability to maintain office files and follow standard office procedures
- Ability to negotiate, persuade and establish direction
- Ability to organize workflow
- Ability to perform basic filing, office procedures and word processing
- Ability to work as an effective team member
- Knowledge of medical terminology
- Phlebotomy skills required for
CRO |
Certificates/Credentials/Licenses |
Bachelors Degree OR equivalent training acquired via work experience or education |
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 |
03/09/2023 |
Close Date |
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Special Instructions to Applicants |
Loyola
all Health Sciences Campus Faculty and Staff to be
with the original COVID-19 and Flu vaccines when eligible. An e
for a qualified medical or religious reason may be submitted for review/approval. |
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
. 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
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 |
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