Clinical Research Coordinator - LHI Cardiovascular
Company: University of Minnesota
Location: Saint Paul
Posted on: January 23, 2023
|
|
Job Description:
Apply for JobJob ID347523
LocationTwin Cities
Job FamilyResearch-Support
Full/Part TimeFull-Time
Regular/TemporaryRegular
Job Code8352P2
Employee ClassCivil Service
Add to Favorite JobsEmail this JobAbout the Job
The Cardiovascular Division is a growing, dynamic clinical research
unit that supports the physician's research portfolio in all
sections of Cardiology including: Interventional, Heart Failure,
Imaging, Vascular Disease, Structural Heart Disease, Prevention,
and Electrophysiology to name a few. The Clinical Research
Coordinator works closely with the research nurse and study
investigators by coordinating complex clinical research projects,
and is responsible for overall protocol management from start up to
close out.
With guidance, this position is responsible to coordinate clinical
research studies including duties that are broad in nature as
outlined in the protocol. Apply knowledge of Good Clinical
Practices and the Code of Federal Regulations to ensure compliance.
This position requires excellent interpersonal and communication
skills, attention to detail and organizational skills. This
position requires the ability to work both independently and as
part of a team, the ability to handle multiple projects and
priorities to provide safe, quality care to research
participants.
Study coordination (30%) - Assist research nurse with therapeutic
trials and/or independently coordinate clinical trials.
* Assist with participant recruitment and screening for available
trials and studies.
* Consent and explain study to new patients/family members.
* Perform screening related activities as per protocol specific
guidelines
* Register patients and schedule return study visits.
* Complete all required study documentation
* Facilitate the timely review and reporting of adverse reactions
and severe adverse events per sponsor, FDA and institutional
requirements.
* Schedule/conduct study monitor visits as directed by study
sponsor.
* Maintain working knowledge of assigned protocols and disease
background.
* Work with nurse coordinator and IRB Specialist to update patient
on study amendments and re-consenting process.
* Communicate with principal investigator to ensure study specific
procedures are completed.
* Complete study-required procedures (e.g. vital signs, EKG, 6
minute walk test, specimen processing/shipping)
* Maintain good clinical practice and open communication with
patients/family members/providers.
* Effectively work independently in multiple locations with
hospital and clinic staff to complete research related tasks
Data management (30%)
* Complete electronic case report forms (eCRFs)
* Respond to monitor issues queries.
* Enter patient registration and visit dates in various databases
(OnCore).
* Document patient related visits in medical chart, as
necessary.
* Review patient charts and records to abstract appropriate
research related information.
* Maintain working knowledge of medical terminology, critical lab
values, and understanding of medical conditions.
* Maintain working knowledge of various sponsor specific databases
and portals.
* Manage follow up schedule and perform follow up via patient phone
call or record search.
Regulatory (25%)
* Assist with the preparation of regulatory applications, consent
forms, etc. Track regulatory review submissions to ensure deadlines
are met.
* Support the maintenance of regulatory binders and required
documentation for each clinical research study to ensure compliance
and to be audit-ready at any given time.
* Prepare for and participate in site initiation visits, monitoring
visits, program audits, etc.
* Report Unanticipated Problems according to University policy.
Administration and Meetings (10%)
* Facilitate new project development
* Support quality improvement initiatives
* Attends national and study meetings as appropriate
* Participate in staff, team and department meetings
Education (5%)
* Educate University faculty and staff of our regulatory and
research obligations in relation to our clinical research
activities
* Communicate with clinical teams to foster an environment of
quality research participation within the context of exceptional
clinical care
Qualifications
All required qualifications must be documented on application
materialsRequired Qualifications:
* Bachelor's degree in a health related field plus 2 years of work
experience in research; or a combination of related education and
work experience in research totaling 6 years.
* Experience and knowledge in a medical or clinical setting
conducting clinical trials and/or clinical research
* Available to work a flexible schedule
* Strong organizational, communication and time management
skills.
Preferred Qualifications:
* Certification as a Clinical Research Coordinator (CCRC, CCRP)
* Certified Medical Assistant or similar experience in
hospital/clinical setting with phlebotomy, vital signs, ECG
experience
* Experience with research databases (REDCap, OnCore, Medidata,
etc.)
* Experience with EPIC
* Knowledge of clinical research regulations (GCP, FDA, CFR,
etc.)
* Proficient with database management, excel spreadsheets, etc.
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:
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 - LHI Cardiovascular, Healthcare , Saint Paul, Minnesota
Click
here to apply!
|