"Clinical Research Coordinator, SOM, Internal Medicine, Pulmonary Division-608100"

Job Details

Unit: School Of Medicine MBU

Department: SOM, Internal Medicine, Pulmonary Division

Department Summary: 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.

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.

Duties & Responsibilities:

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.

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.

Core Responsibilities:

• 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
• Coordinate various clinical research programs dealing with diagnostic and therapeutic aspects of lung disease and its complications under the direction of physicians within the Pulmonary 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

Additional Information:

ORP Eligible: - NO
Hours / weeks - 40 hours weekly
Title Details: Clinical Research Coordinator
UNIVERSITY JOB CODE: Clinical Research Coordinator, RS 1-3 (34111N-34113N)

University Code: (34111N-34113N)

University Job Family: Research & Innovation

Qualifications:

Minimum Qualifications

• 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 ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff and students from various backgrounds and experiences, or a commitment to do so as a staff member at VCU

Preferred Qualifications

• 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

Salary Range: $50,000-$65,000

Benefits: All full-time university staff are eligible for VCU’s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt

Hours per Week: 40

Restricted Position: Yes

ORP Eligible: No

Flexible Work Arrangement: Fully Onsite

University Job Title: 3411B - Clinical Research Coordinator Base

Contact Information: Demetria Patterson
Contact Name: Demetria Patterson
Contact Email: demetria.patterson1@vcuhealth.org