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Clinical Research Coordinator (PRA)

Job description





University of Colorado - School of Medicine

Clinical Research Coordinator - PRA

The University of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

The University of Colorado's Division of Gastroenterology and Hepatology in the Department of Medicine, located at the Anschutz Medical Campus, is an internationally renowned program that provides comprehensive resources for the diagnosis and therapy of diseases of the digestive tract, pancreas and liver. The Division of Gastroenterology and Hepatology has faculty and staff making contributions to research, clinical trials, and nationally recognized patient care. Gastroenterology & GI Surgery is one of the top ranked in the United States and our clinical partner, the University of Colorado Hospital, and is in the top hospitals nationwide as ranked by U.S. News and World Report. The Division of Gastroenterology and Hepatology is rapidly growing, with clinical practices throughout the state of Colorado and over 80 researchers, physicians and staff, all working toward its vision to prevent and treat disease while being a global model for patient care delivery, interdisciplinary research, and training.

As an important member of the research team, the Clinical Research Coordinator works with industry-sponsored, co-operative group and/or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. This position is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. This position is responsible for coordinating study subject appointments throughout the study as well as scheduling, coordinating, and preparing for monitoring visits and audits. The incumbent is responsible for data entry and resolution, study subject advocacy; and possible management of studies at the local level. This position communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all.

The Division of Gastroenterology and Hepatology is seeking to employ a full time Professional Research Assistant (Clinical Research Coordinator) to assist Dr. Mark Gerich with clinical trials focusing on and related to inflammatory bowel disease. This position is responsible for the implementation and coordination of clinical trials conducted by faculty members at the University of Colorado.

Examples of Work Performed

  • Obtains study subject medical history and current medication information, reviews research protocol Inclusion/Exclusion Criteria, and confirms eligibility of subject to participate in clinical trial. Performs informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
  • Interviews prospective subjects for a variety of research clinical trials. Educates potential subjects on the details of the studies through phone contacts and personal interviews
  • Schedules subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
  • Familiar with protocol and all study documents and reviews documents after each study subject visit for completeness and accuracy
  • Abstracts and records all research subject data pertaining to the research protocol onto protocol-specific Case Report Forms (CRFs) and into the UCCC clinical trials database in an accurate and timely fashion
  • Ensures complete source documentation is compiled for each study subject record
  • Provides review of patient eligibility determination by:
    • Gathering source documentation
    • Ensuring the most current and approved version(s) of the study informed consent forms are completed and that the informed consent process is properly documented and consent form filed
    • Reviewing study subject Medical History to determine eligibility status
  • Assesses for clinical significance of all lab and test results and relatedness of adverse reactions to study product according to protocol guidelines
  • Schedules and tracks submission of Prescreening, Screening and Enrollment Logs, as required by Sponsor
  • Reports subject Adverse Events (AEs) and Serious Adverse Events (SAEs) to appropriate parties (e.g., Principal Investigator, Study Sponsor, Food and Drug Administration (FDA), Data and Safety Monitoring Committee (DSMC), Regulatory Affairs Coordinator, etc.)
  • Meets with Monitors to respond to any question of data validity and corrects/revises data as appropriate; responds to queries from Sponsor
  • Works on multiple research studies simultaneously
  • Serves as a liaison with Sponsors and with study subjects for ongoing clinical research studies
  • Independently coordinates and manages data entry, queries, and monitor visits
  • Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses
  • Collaborates with hospital staff to ensure tests and procedures, required by research protocols, are performed and documented (e.g., vital signs, phlebotomy, specimen processing, electrocardiograms (EKGs), research drug administration, and protocol-specific tests and procedures)
  • May be trained to perform the following on study subjects:
    • Electrocardiograms
    • Measurement of blood pressure, pulse, height, weight, and temperature
    • Phlebotomy (direct venipuncture)
    • Research specimen collection, processing and shipping
  • Develops protocol-specific Source Documents (e.g., data collection tools, study visit checklists, pharmacokinetic sample collection worksheets, etc.)
  • Assists Team Manager and/or Financial Team by processing bills and/or answering billing questions related to procedure performed for subjects enrolled in clinical trials
  • Serves as Primary Coordinator for clinical trials
  • Assists Team Supervisors with creation and conduct of process and quality improvement projects


Salary and Benefits

Salary is commensurate with skills and experience. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services.

The University of Colorado Denver is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

The Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Benefits: https://www.cu.edu/employee-services/benefits.

Total Compensation Calculator: https://www.cu.edu/employee-services/total-compensation

Diversity and Equity

Please click here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx

The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.


Qualifications

Minimum Requirements

  • A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
  • At least 1 year of clinical research experience.


Substitution: Any equivalent combination of Education or Experience can substitute for the degree on a year for year basis, but not for the specific experience.

Preferred Qualifications

  • 3 years of clinical research experience
  • Gastroenterology and/or Hepatology Clinical Research experience
  • Experience working with RedCap
  • Experience working with an electronic medical record; experience with EPIC is strongly preferred.
  • Experience with database software (such as MS Access)
  • Experience with statistical software
  • Clinical Research Certification (i.e., Certified Clinical Research Coordinator (CRC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA)


Knowledge, Skills and Abilities

  • Ability to communicate effectively, both in writing and orally.
  • Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
  • Outstanding customer service and patient relations skills.
  • Demonstrated commitment and leadership ability to advance diversity and inclusion.
  • Excellent organizational skills, ability to problem-solve, multi-task, and work independently.
  • Good command of the English language, both written and verbal.
  • Excellent attention to detail.
  • Ability to interpret and comprehend complex research protocol information.
  • Excellent computer skills including proficiency in Microsoft Office products.
  • Knowledge of basic human anatomy, physiology, medical terminology.



Application Materials Required:Cover Letter, Resume/CV, List of References

Application Materials Instructions:

Applications are accepted electronically at CU Careers, refer to requisition ID: 15216

When applying, applicants must include:
  1. A letter of application which specifically addresses the job requirements and outlines qualifications
  2. A current Resume/CV
  3. The names, addresses, daytime telephone numbers and e-mail addresses for three professional references, either attached to your resume/CV or uploaded as a separate document
Please be advised that the University does check references as part of the employment process.

Please do not submit any of your application material (via email) to the job posting contact.



Job Category: Faculty

Primary Location: Aurora

Department: H0001 -- Anschutz Medical Campus - 20189 - SOM-MED-Gastroenterology

Schedule: Full-time

Posting Date: Nov 29, 2018

Closing Date: Ongoing

Posting Contact Name: Spencer LaFasto

Posting Contact Email: [email protected]

Position Number: 00050193

PI105900635

 

 

 

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Job No:
Posted: 11/30/2018
Application Due: 12/13/2018
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