Job Description

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. Continuing education for undergraduate and graduate tuition for a maximum of 6 credits per semester; Professional development opportunities encouraged and offered for employees as part of annual career development, e.g. certifications, seminars, courses, annual conferences, mentorship; 28 Vacation Days, 12+ State Holidays, and 4 Days to volunteer; Medical, Dental and Vision Health Benefits to meet the needs of employees and their eligible family members from the Commonwealth of Virginia as well as optional FSA; Participation in the Virginia Retirement System (VRS) and other retirement saving options; Parental and Caregiver Leave, Short Term Disability (STD), Disability Insurance, Voluntary Long Term Care Insurance, and Employee Assistance Program. Unit Unit: Massey Comprehensive Cancer Ctr MBU Department Department: Massey Clinical Trials Office Department Summary Mission: To reduce the state cancer burden for all Virginians by addressing the confluence between biological, social, and policy drivers through high-impact, cutting-edge research; person-centered care across the continuum, from prevention through survivorship; community integration; and training the next generation of community-centric researchers and healthcare professionals. Vision: To be a premier community-focused cancer center leading the nation in cancer health equity research and ensuring optimal health outcomes for all. Position Primary Purpose and General Responsibilities Clinical Data Managers generally perform administrative and study related duties that are essential to the successful management of research conducted by principal investigator(s) at the university. This position may support human subject research that is not conducted in a clinical or health care environment or does not require access to clinical facilities, systems, or data. Typical duties may include scheduling and monitoring of research activities and timelines; coordinating the management, storage, and reporting of study data; monitoring data to maintain quality control; and scheduling and booking monitoring visits. They may work independently or as a member of a team. They work under general supervision, resolving most standard issues independently and referring complex issues to an upper-level manager. Clinical Data Managers typically report to a manager or director or may report to a department administrator. NOTE: Maintain established portfolio driven knowledge base of federal and state laws and regulations, sponsor guidance as well as university policies and compliance notices, with ability to consistently interpret and apply accurately. Job Description Assist with participant recruitment, enrollment, tracking, data collection, and verification of data in the study database Maintain understanding of clinical research management duties from study initiation to closeout Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), and additional certifications as required Engage in various forms of communication about the studies they are assisting Understand and adhere to all IRB requirements, Human Subjects Protection regulations, and all aspects of the IRB approved protocol Coordinate and ensure access for monitoring and auditing visits Responsible for all data entry of protocol required visits and procedures Respond to data queries as assigned Assigned to assist different teams based on resource needs Clean up any prior data discrepancies Assist with sample preparation, collection and processing as needed Collect survival follow-up data on applicable participants Comply with VCU Health’s (VCUH) clinical research clinical permissions table Ensure compliance and adherence to clinical research protocols Ensure studies are audit ready Ensure all study data is captured in OnCore and comply with department policies Follow VCU internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards Other duties as assigned Qualifications Minimum Qualifications High School Diploma or equivalent Must be able to complete mandatory competencies and certifications required by VCU and VCU H, individual clinical trials and the NIH Human Subjects Protection training Preferred Qualifications Bachelor’s degree or equivalent combination of training and experience preferred Certification from the Society of Clinical Research Associates (SOCRA), the Association of Clinical Research Professionals (ACRP) or CRA certification for Research Administration. Previous experience in oncology clinical research preferred VCU is not able to provide ongoing visa sponsorship for this position. Please note that if you are employed as a university employee working in any of the health system's facilities, you will need to follow VCU Health System policies, which will include but will not be limited to, vaccination requirements. VCU is committed to hiring veterans! VCU will include a veteran’s period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual! Salary Range: Commensurate with experience, range minimum of $44,000 FLSA Exemption Status: Non-Exempt Restricted Position: No ORP Eligible: No Flexible Work Arrangement: Hybrid University Job Title: 93406 - Open Contact Email: masseyhr@vcu.edu #J-18808-Ljbffr Virginia

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