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Clinical Research Coordinator (CRC)

Employer
Virginia Commonwealth University
Location
Virginia, United States
Salary
Salary Not Specified
Date posted
Dec 4, 2020

Position Information

University Code 34111 University Title Clinical Research Coordinator 1 University Job Family Research - Support ORP Eligible No For more information on ORP, visit: Retirement Plans
Recruitment Pool All Applicants Recruitment Type Single Title Scope of Search Local Working Title Clinical Research Coordinator (CRC) Position Number 547840 Is this employee on a H1B Visa? Position Type Staff Job Status Full-Time FLSA Indicator Non-Exempt Employee Group University Employee Department School of Nursing Organizational Overview

At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.

Position Primary Purpose and General Responsibilities

We invite applicants to apply for the Clinical Research Coordinator position. The Clinical Research Coordinator ( CRC ) is a specialized research professional who will work with and under the direction of the Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily research activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

The clinical research coordinator reports primarily to the Principal Investigator.

• Conduct clinical research activities as authorized by the Principal Investigator’s documented Delegation of Authority and Training Logs.
• Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice ( GCP ), Clinical Research Coordinator, plus additional sponsor GCP certifications as required.
• Work independently and closely with patients and physicians
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols.
• Conduct all assigned activities in compliance with national, local, & institutional guidelines, according to all HIPAA, GCP, and other applicable requirements. Activities include coordinating: new study activation requirements, screening/enrolling participants, regulatory and compliance requirements, maintaining appropriate study documentation/records, and managing study data.
• Coordinate various clinical research programs dealing with diagnostic and therapeutic aspects of cardiovascular disease and its complications under the direction of physicians within the Cardiology Division
• Ensure patient safety is a top priority in conducting clinical trials.
• Ensure all IRB submissions are complete and submitted on time.
• Maintain regulatory binders in audit ready state- ensuring all documentation is complete and has been submitted to the IRB .
• Provide timely and courteous responses to queries from patients, faculty and sponsors.
•Complete and ensure accurate effort reporting is recorded

Minimum Hiring Standards

• Demonstrated knowledge and understanding of clinical research management duties from study initiation to close-out to include: regulatory, human subject’s protection, study conduct, and data management requirements.
• Excellent communication, writing, and interpersonal skills.
• Exhibits professionalism and ability to work both independently and collaboratively as part of a team; establishing and maintaining productive relationships with VCU colleagues and all customers and contacts necessary to effectively support research studies.
• Must be able to prioritize work requirements and multi-task in a fast-paced environment, seeking guidance from Principal Investigators and senior study team staff when necessary.
• Ability to read, interpret, and apply complex regulations, policies, and requirements for each study assigned.
• Excellent organization, time management and critical thinking skills.
• Able to provide own transportation to service areas and meeting locations.
• Participate in professional education and advancement opportunities to facilitate personal and program growth.
• Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU .

Preferred Hiring Standards

• Previous research experience working with women, infants, or children
• Experience managing projects
• Familiarity with Cerner and VCU Health strongly preferred.
• Experience with Trello, Google Office, Redcap and analytical data reporting

Required Licenses/ Certifications Anticipated Hiring Range $52,000 - $60,000 Application Process/Additional Information Campus MCV Campus Hours/Week 40 Normal Work Days/Hours Monday - Friday/8:00am - 5:00pm Job Open Date 12/04/2020 Posting will close on or before Open Until Filled Yes Job Category Research Is this a restricted position? Yes Is this position eligible to participate in alternative work arrangements? Yes Sensitive Position No Resource Critical Yes Quick Link https://www.vcujobs.com/postings/102078 Posting Specific Questions

Required fields are indicated with an asterisk (*).

  1. * Please describe your experience with clinical research and any experience working in a laboratory/medical research environment.

    (Open Ended Question)

  2. * Please describe your experience in research administration, including managing and reviewing clinical research regulatory submission, and number of years.

    (Open Ended Question)

  3. * Please describe your knowledge of the conduct of research and human subjects protections regulations.

    (Open Ended Question)

  4. * Please describe any experience working in a fast paced research environment.

    (Open Ended Question)

  5. * Are you familiar with Cerner?
    • yes
    • no
  6. * Please describe your experience using RedCap?

    (Open Ended Question)

  7. * Are you able to provide your own transportation?
    • Yes
    • No
Optional & Required Documents
Required Documents
  1. Cover Letter/Letter of Application
  2. Resume
Optional Documents

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