Clinical Research Coordinator School of Medicine Clinical Research Office

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCUs sponsored research the School of Medicine is internationally recognized for patient care and education.

Position Summary &Core Responsibilities:

The School ofMedicine (SOM) Office of Research Administration is seeking candidates withskills in clinical research coordination to join our Clinical Research Office(SOMCRO). The CRC role is part of a team focused on coordination services forSOM investigators. This position provides potential for career growth in thefield of clinical research management for those presenting a willingness tolearn and ability to work collaboratively with a diverse group of faculty andstaff.

Working under thedirection of the Senior Program Manager within the Clinical ResearchCoordinator Pool for SOMCRO key responsibilities include supporting SOMInvestigators in the daytoday activities required for activation executionand management of clinical patientoriented research studies or protocols. TheCRC will be directly responsible for study coordination of clinical researchstudies covering a variety of diseases and conditions. Additionally the roleincludes maintaining current CITI credentials for Human Subjects ProtectionGood Clinical Practice (GCP) and other necessary certifications.

Responsibility 1 50: Clinical ResearchConduct and Coordination

• Manage the daytoday clinical research activities of assigned studies including study activation regulatory compliance human subject protection study recruitment conduct data management and study closeout.
• Perform staff inservice/education for ancillary units (e.g. laboratory radiology Investigational Drug Service) involved in the study.
• Screen for potential research participants through evaluation of patients using inclusion/exclusion criteria and protocolspecified eligibility requirements.
• Coordinate with physician investigators to explain research studies to potential participants and ensure that informed consent is obtained prior to the initiation of studyrelated procedures.
• Ensure proper administration/ of informed consent and ongoing consent of study participants.
• Coordinate with physician investigators to monitor and manage patients care on research protocols.
• Maintain confidentiality.
• Participate in crosstraining and crosscoverage for other members of the pool ensuring no lapse in administrative aspects of study management or study conduct for studies managed by SOMCRO.
• Crosscoverage across studies and working with the SOMCRO team in true collaboration.
• Complete assigned clinical research activities in a compliant and efficient manner.
• Manage study coordination activities for studies supported by a pool of clinical research coordinators or other study team personnel.

Responsibility2 20: Data Management and Documentation

• Collect record and maintain records of all data collected for research participants.
• Ensure safekeeping of records during the study and for the designated period after study closure.
• Ensure timely and accurate data entry into OnCore (clinical trial management system) for both studylevel and participantlevel data for studies in the portfolio.
• Prepare or assist with required regulatory and IRB ongoing study documentation including annual progress reports protocol amendments and safety reports.
• Enter study data for new and ongoing clinical research studies.
• Assist with the review and response to all sponsor queries as assigned and within required time frames.
• Ensure all documentation is complete.

Responsibility 3 20: Regulatory &Compliance Requirements

• Ensure proper research protocol compliance.
• Conduct clinical research activities as authorized by Delegation of Authority and Training Logs.
• Assist in the preparation and collection of all necessary study documentation.
• Participate in SOMCRO internal meetings.
• Ensure accuracy of subject data and compliance with research protocol and regulatory requirements.
• Participate in auditing and monitoring activities as assigned.
• Maintain study files according to GCP guidelines and in auditready condition.

Responsibility 4 10: Excellence in CustomerService and Team Dynamics

• Provide clear communications to our investigators and study sponsors.
• Understand the importance of ownership of tasks and responsibilities.
• Grow relationships with stakeholders and ensure we deliver on the services provided.
• Develop and nurture relationships with investigators members of the study teams departmental personnel colleagues and coworkers throughout VCU SOM and VCUHS.
• Communicate with clinical trial sponsors as appropriate (e.g. study activation responsibilities essential document collection and ongoing study management and coordination).
• Serve as a liaison between industry sponsors contract research organizations faculty investigators and the institution for promoting the conduct of clinical research at the institution and managing expectations and workflow for specific protocols.

Position will remain open until filled.

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.

VCU is committed to hiring veterans! VCU will include a veterans period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!

Preferred Qualifications

• Familiarity with Epic and VCU Health is strongly preferred.
• Clinical Coordination experience at an Academic Institution is preferred.
• Experience with OnCore is preferred.
• Familiarity with Veeva SiteVault is preferred.

Minimum Qualifications

• 1 year of experience or more in clinical research coordination including regulatory human subject protection study conduct and data management requirements or equivalent clinical research experience.
• Excellent communication writing and interpersonal skills.
• Professionalism and ability to work both independently and collaboratively as part of a team; establish and maintain productive relationships with VCU colleagues and all customers and contacts necessary to effectively support research studies.
• Ability to prioritize work requirements and multitask in a fastpaced environment seeking guidance from Principal Investigators and senior study team staff when necessary.
• Excellent organization time management and critical thinking skills.
• Ability to work effectively and collaboratively in a diverse environment required.
• Ability to work independently and as a member of a team.
• Must be able to complete mandatory competencies and certifications required by VCU and VCUHS individual clinical trials and the NIH Human Subjects Protection training.
• Ability to set priorities make timely decisions and meet deadlines while working on multiple projects.
• Previous patient care exposure in a clinical setting.
• Demonstrated experience working in and fostering 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.

Liliana Valladares

Required Experience:

IC