Clinical Research Coordinator

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 Position Number 590250 Is this employee on a H1B Visa? Position Type Staff Job Status Full-Time FLSA Indicator Exempt Employee Group University Employee Department Internal Medicine 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

For all clinical research studies assigned, the Clinical Research Coordinator is responsible for coordinating clinical research studies in a compliant and efficient manner. Under the direction of the Principal Investigator (PI), collaborate will all members of the clinical research team to ensure all federal, state, university, and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept. Key responsibilities include:
• Demonstrated understanding of clinical research coordinating duties from study initiation to close-out.
• 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.
• Complete initial IRB submissions, annual continuing reviews, amendments, and reliance agreements for clinical trials
• Prepare and submit essential study documents for clinical trials
• Assist with protocol and informed consent creation

• 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.

Minimum Hiring Standards

• Excellent communication, writing, and interpersonal skills.
• Exhibits professionalism and ability to work both independently and collaboratively as part of a team; establishing and maintain 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 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.
• Ability to work effectively and collaboratively in a diverse environment required

Preferred Hiring Standards

• Previous patient care exposure in a cardiovascular setting.
• Research experience and direct patient care experience with patients with cardiovascular disease
• Familiarity with Cerner and VCU Health strongly preferred.

Required Licenses/ Certifications

Active clinical licensure such as: CNA, CMA, EMT, or LPN, or RN

Anticipated Hiring Range Commensurate with Experience Application Process/Additional Information Campus MCV Campus Hours/Week 40 hours/weekly Normal Work Days/Hours Mondat - Friday/ 8:00 am -5:00 pm Job Open Date 03/17/2021 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? No Sensitive Position Yes- A pre-employment fingerprint background check will be required. Resource Critical No Quick Link https://www.vcujobs.com/postings/104370 Posting Specific Questions

Required fields are indicated with an asterisk (*).

1. * Please describe your work experience, education, and training that is directly related to this position.
   
   (Open Ended Question)
   
   
2. * Please describe your experience pertaining to IRB submissions and communications with an IRB.
   
   (Open Ended Question)
   
   
3. * Please describe your proficiency in Microsoft Word, Excel, Access, or other related technology systems.
   
   (Open Ended Question)
   
   
4. * Please describe the way you prioritize your work and tasks when presented with multiple projects concurrently
   
   (Open Ended Question)
   
   

Optional & Required Documents
Required Documents Optional Documents

1. Cover Letter/Letter of Application
2. Resume