Clinical Research Coordinator II
Company: University of Minnesota
Location: Saint Paul
Posted on: January 28, 2023
|
|
Job Description:
Apply for JobJob ID352101
LocationTwin Cities
Job FamilyResearch-Support
Full/Part TimeFull-Time
Regular/TemporaryRegular
Job Code8352P2
Employee ClassCivil Service
Add to Favorite JobsEmail this JobAbout the Job
JOB SUMMARY
The Clinical Research Coordinator II is responsible for providing
technical expertise and overall management of clinical research
data collection, study documentation, protocol-required procedure
execution, and collaboration with PI and study team to ensure
consistent and accurate implementation of the protocol. The
incumbent will be expected to follow Good Clinical Practice (GCP)
and all organization policies and procedures for patient safety and
data integrity, including but not limited to the Institutional
Review Board (IRB), Food & Drug Administration (FDA), Code of
Federal Regulations (CFR), and International Conference on
Harmonization (ICH) guidelines.
SPECIFIC RESPONSIBILITIES
Trial Management / Study Coordination (60%)
* Interprets protocols and creates source documents needed for
clinical research study
* Identifies and reports protocol deviations within the required
timeline in accordance with institutional requirements
* Ensures protocol adherence by communicating and ensuring study
parameters are executed according to protocol
* Oversees visits with outside sponsors, including site initiation
visits, interim monitoring visits and closeout visits
* Collaborates with PI and study team to enroll study participants,
execute study-required procedures, and maintain accurate source
documentation
* Maintains a processing and tracking system for protocol-required
biospecimens, data, and procedures
* Works as a member of the study team with positive and timely
written and verbal communication, including sharing information up,
down, and laterally
* Troubleshoots problems in the development and implementation of
protocol procedures
* Coordinates with Investigational Drug Services (IDS), BioNet,
clinical staff, and other bodies across campus to deliver drug,
collect biospecimens, and execute the study visits according to
protocol
Data Management (40%)
* Serves as primary contact for the collection and completion of
required study documentation
* Develops and maintains study documentation to ensure audit-proof
compliance
* Abstracts data from medical record to ensure accurate and
complete source documentation
* Manages electronic data capture systems, including but not
limited to building the case report forms, responding to queries,
and meeting data lock deadlines
* Demonstrates proficiency with Common Terminology Criteria for
Adverse Events (CTCAE), medical terminology, critical lab values,
and other disease-specific diagnostic
criteria
Qualifications
All required qualifications must be documented on application
materials. REQUIRED QUALIFICATIONS
* BA/BS with at least 2 years of experiences or 6 years of relevant
education & healthcare or research experience
* Excellent attention to detail and organizational skills
* Ability to work independently, as part of a team, and with
changing priorities
* Computer proficiency in a PC environment including Microsoft
Office products
* Ability to sit for extended periods of time
PREFERRED QUALIFICATIONS
* Oncology research experience in an academic setting
* Experience with patient contact / care
* Experience abstracting clinical data and familiarity with medical
terminology
* Clinical Research Coordinator certification
* Experience with Epic, Oncore, or equivalent medical record /
Clinical Trial Management
Systems
About the Department
The Masonic Cancer Center (MCC) is an NCI-designated Comprehensive
Cancer Center dedicated to cancer research, education, and patient
care for the citizens of Minnesota and the surrounding region.
Since the time of the first award in 1997, there has been
consistent growth of the membership and research base, enabling our
center to further advance our knowledge and enhance care for our
catchment area. We are driven to be the choice academic healthcare
environment for patients, clinicians, scientists and students who
seek exceptional, compassionate, precision cancer therapy;
innovative clinical trials and prevention programs; cutting-edge
research opportunities; and outstanding advanced education.
Benefits
Working at the UniversityAt the University of Minnesota, you'll
find a flexible work environment and supportive colleagues who are
interested in lifelong learning. We prioritize work-life balance,
allowing you to invest in the future of your career and in your
life outside of work.The University also offers a comprehensive
benefits package that includes:
How To Apply
Applications must be submitted online. To be considered for this
position, please click the Apply button and follow the
instructions. You will be given the opportunity to complete an
online application for the position and attach a cover letter and
resume.Additional documents may be attached after application by
accessing your "My Job Applications" page and uploading documents
in the "My Cover Letters and Attachments" section.To request an
accommodation during the application process, please e-mail
employ@umn.edu or call (612) 624-UOHR (8647).
Diversity
The University recognizes and values the importance of diversity
and inclusion in enriching the employment experience of its
employees and in supporting the academic mission. The University is
committed to attracting and retaining employees with varying
identities and backgrounds.The University of Minnesota provides
equal access to and opportunity in its programs, facilities, and
employment without regard to race, color, creed, religion, national
origin, gender, age, marital status, disability, public assistance
status, veteran status, sexual orientation, gender identity, or
gender expression. To learn more about diversity at the U:
http://diversity.umn.edu.
Employment Requirements
Any offer of employment is contingent upon the successful
completion of a background check. Our presumption is that
prospective employees are eligible to work here. Criminal
convictions do not automatically disqualify finalists from
employment.
Please note: All employees at the University of Minnesota are
required to comply with the University's Administrative Policy:
COVID-19 Vaccination and Safety Protocol by either providing proof
of being fully vaccinated on their first day of employment, or
complete a request for an exemption for medical exemption or
religious reasons. To learn more please visit:
https://safe-campus.umn.edu/return-campus/get-the-vax
About the U of M
The University of Minnesota, Twin Cities (UMTC)The University of
Minnesota, Twin Cities (UMTC), is among the largest public research
universities in the country, offering undergraduate, graduate, and
professional students a multitude of opportunities for study and
research. Located at the heart of one of the nation's most vibrant,
diverse metropolitan communities, students on the campuses in
Minneapolis and St. Paul benefit from extensive partnerships with
world-renowned health centers, international corporations,
government agencies, and arts, nonprofit, and public service
organizations.
Keywords: University of Minnesota, St. Paul , Clinical Research Coordinator II, Healthcare , Saint Paul, Minnesota
Click
here to apply!
|