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:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF)
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no costPlease visit the for more information regarding benefits.
  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