Clinical Data Manager, CSRN

About the role

Department: Massey Clinical Trials Office, Massey Comprehensive Cancer Center MBU.

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.

Clinical Data Managers perform administrative and study-related duties essential to the successful management of research conducted by principal investigators. This position may support human subject research not conducted in a clinical or health care environment or not requiring access to clinical facilities, systems, or data. Typical duties include scheduling and monitoring research activities and timelines; coordinating management, storage, and reporting of study data; monitoring data for quality control; and scheduling and booking monitoring visits. Work is performed under general supervision, resolving most standard issues independently and referring complex issues to an upper-level manager. The role maintains an established portfolio-driven knowledge base of federal and state laws and regulations, sponsor guidance, and university policies and compliance notices, with the ability to consistently interpret and apply them accurately. This recruitment is open for three (3) separate Clinical Data Manager positions.

Responsibilities

• 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 Health, individual clinical trials, and the NIH Human Subjects Protection training
• 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
• Advanced proficiency with data entry and word processing skills, with the ability to analyze and interpret information effectively
• Advanced organizational abilities and a keen eye for detail to ensure accuracy and efficiency in all tasks with the ability to multitask and prioritize autonomously
• Clear and professional written and verbal communication skills, with the ability to interact effectively with colleagues and stakeholders
• Interpersonal skills, capable of building relationships and collaborating with team members at all levels to gather information and support compliance efforts
• Problem-solving and organizational aptitude, with the ability to manage multiple tasks, meet deadlines in a dynamic environment and independently make critical decisions

Preferred Qualifications

• Bachelor’s degree or equivalent combination of training and experience
• 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
• Spanish speaking

Benefits

• Comprehensive health benefits (Medical, Dental, Vision) for employees and eligible family members from the Commonwealth of Virginia, plus optional FSA
• Paid annual and holiday leave granted up front: 28 Vacation Days, 12+ State Holidays, and 4 Days to volunteer
• Generous tuition benefits: Continuing education for undergraduate and graduate tuition for a maximum of 6 credits per semester
• Professional development opportunities encouraged and offered as part of annual career development (certifications, seminars, courses, annual conferences, mentorship)
• Retirement planning and savings options: Participation in the Virginia Retirement System (VRS) and other retirement saving options, tax-deferred annuity and cash match programs
• Employee discounts
• Well-being resources
• Abundant opportunities for career development and advancement
• Parental and Caregiver Leave, Short Term Disability (STD), Disability Insurance, Voluntary Long Term Care Insurance, and Employee Assistance Program

Pay

Commensurate with experience, range minimum of $44,000. FLSA Non-Exempt.

Schedule

Hybrid work arrangement.

University Job Title: 93406 - Open. Contact: masseyhr@vcu.edu. Restricted Position: No. ORP Eligible: No.