Floating 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

Under direct supervision, this position will be responsible for supporting Principal Investigator(s), clinical research coordinators, and other more senior members of a clinical study team with administrative, regulatory, and data management tasks as assigned. Key tasks may include: case-finding, evaluation and abstraction of source documentation, case report form completion, database use and management (including our institutional CTMS), data abstraction and organization for presentation/publications. Responsible for subject data management and maintaining source documents and subject files according to Good Clinical Practice. May assist with preparing and shipping medical samples/specimens to/from appropriate labs, providing administrative support to study activation processes and regulatory maintenance of assigned studies.

The CDM Floater will be dedicated to the Massey Clinical Trials Office. The CDM Floater works closely with the Assistant Director of Clinical Research Operations and Workforce Development to support continuing data entry clean up and compliance for all studies across disease working groups. The CDM Floater will also function as a Patient Pre-Screener to assist teams in identifying potential study candidates. This role 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.

• Data, Entry, Management and Collection: assist with enrollment, tracking, data collection, data processing/resolution (discrepancies, audits, reconciliations, monitoring visits, queries etc.), verification and archiving of data in study databases for multiple projects from multiple sponsors. Reactively clean data backlogs. Work with the Deep 6 Clinical Research Nurse Analyst to help identify potential patients. Inform study teams of Deep 6 identified potential patients to approach at next appointment. Assist in study lab kit organization and upkeep. Assist in updating and correcting the staff assignments in OnCore at the patient level “on study” tab. 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.