Clinical Data Manager

Benefits At a Glance

• Up to 5 remote days per month upon successful completion of training and leadership approval;
• 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.

Massey Comprehensive Cancer Center

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

A Clinical Data Manager (CDM) within the Clinical Trials Office of Massey Comprehensive Cancer Center at VCU is responsible for the collection, entry and management of data for multiple projects from multiple Sponsor sources including national, pharmaceutical and Investigator-Initiated Sponsors. A CDM performs administrative and study related duties that are essential to the successful management of research conducted by principal investigator(s) at the university. A CDM works with internal and external study members to make sure data is collected, managed, cleaned and reported clearly and accurately for all trials assigned to your team. Typical duties may include scheduling and monitoring of research activities and timelines; conducting participant interviews, administering study related assessments, and recording observations; coordinating the management, storage, and reporting of study data; monitoring data to maintain quality control; purchasing supplies and tracking expenditures; summarizing study results; preparing reports; and scheduling and booking facilities. A CDM 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.Each CDM reports to a Clinical Operations Manager who oversees disease working group specific teams within the Clinical Research Operations Unit. This roles reports in-person in downtown Richmond, Virginia with the flexibility to work hybrid 5 days/month post-review, 3-6 months training and manager approval,

• Recruitment, Enrollment, Retention, and Data Collection; assist with participant recruitment, enrollment, tracking, data collection, data processing/resolution (discrepancies, queries etc.), verification and archiving of data in the study database for research studies. Maintain all data management documentation following standard practice guidelines;
• Engage in various forms of communication about the studies they are assisting; engage in effective communication with the study's Hub Site, community partners, community organizations, social media outlets, research participants, and others;
• Work collaboratively and independently to develop electronic clinical research charts, conduct data retrieval, entry and quality control using eMR, CTMS (OnCore), other IT system and supporting documentation;
  Ensure trial visits, data for study participant tests and samples are done per the study schedule and entered in a timely fashion;
• Understand and adhere to all IRB requirements, Human Subjects Protection regulations, and all aspects of the IRB approved protocol;
• 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;
• Assist the research team including but not limited to the clinical study team coordinator, Clinical Research Nurse, Clinical Research Coordinator and PI with other duties as assigned.