Clinical Research Coordinator, SOM, Division of Nephrology/Transplant Nephrology
3 months ago
School of Medicine, Internal Medicine/Nephrology Division
Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education. VCU School of Medicine comprises 18 clinical departments, eight basic health science departments, and 11 affiliated institutes and centers, and provides preeminent education to physicians and scientists in order to improve the quality of healthcare for humanity. All full-time university staff are eligible for our generous benefits package that includes choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off,12 paid holidays, and more. Explore our benefits further here: Https://hr.vcu.edu/current-employees/benefits/university-and-academic-professional-benefits/.
Position Summary:
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 with 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. Primary components are Study Conduct, Patient Education, Coordination of Care, and Clinical Skills.
Required Duties Include and are not limited to:
•Demonstrated understanding of clinical research management 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.
• 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
Required Education and Experience:
• Experience in clinical research to demonstrate thorough knowledge and understanding of clinical research management to include: regulatory, human subject’s protection, study conduct, and data management requirements, or related experience that would lead to the same.
• 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 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 Experience:
• Previous patient care exposure in a clinical setting.
• Familiarity with EPIC and VCU Health
• Bachelor’s degree in a scientific/healthcare field, or a combination of education and at least 3 years of experience in a clinical research role
Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.
Additional Information:
ORP Eligible: - No
Hours / weeks - 40 hours weekly
Days /hours - Monday - Friday, Generally 8:00 am - 5:00 pm
Title Details:
University Title: Clinical Research Coordinator
University Code: 34111N-34113N
University Job Family: Research
This is a restricted position with no set end date and continued employment is dependent upon project needs, availability of funds, and performance.
The School of Medicine continuously strives for our workplace and learning environment to reflect the demographic and social milieu of the communities we serve. All qualified applicants are encouraged to apply.
Virginia Commonwealth University is an equal opportunity, affirmative action university providing access to education and employment without regard to race, color, religion, national origin, age, sex, political affiliation, veteran status, genetic information, sexual orientation, gender identity, gender expression, or disability.
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