Floating Clinical Data Manager presso Virginia Commonwealth University (VCU)

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 benefit, 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. Learn more about VCU’s benefits here.

Benefits At a Glance

• 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 accommodates flexible work arrangements but does expect monthly in person meetings and additional trips on site as needed.

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  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.

Minimum Qualifications

• Bachelor's degree or equivalent combination of education, experience, and training;
• 2+ years of relevant experience supporting data management activities with an exposure to data processes and flow or equivalent combination of education, training, and experience with the ability to learn basic data entry, understand complex protocols and motivation to learn the foundation of at least one oncology disease area;
• Intermediate proficiency with Microsoft Excel, Word, Access, Outlook, Visio, Smartsheets and Adobe with the ability to adapt to a range of database applications.

Candidates whose resumes highlight the following previous experience will be prioritized: 

• 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;
• Intermediate proficiency with data entry and word processing skills, with the ability to analyze and interpret information effectively;
• Intermediate organizational abilities and a keen eye for detail to ensure accuracy and efficiency in all tasks;
• 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 and meet deadlines in a dynamic environment.

Please note 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.

Preferred Qualifications

• Master's degree or equivalent combination of education, experience, and training; 
• 4+ years of relevant experience supporting data management activities with an exposure to data processes and flow or equivalent combination of education, training, and experience with basic data entry, complex protocols and the foundations of at least one oncology disease area;
• 2+ years experience with EDC software, XML, OnCore, EMR (Cerner or EPIC), RedCap, DEEP6A;
• 2+ years experience with research studies;
• 2+ years evidence of effective communication with research participants and/or patients;
• 2+ years experience working with underrepresented populations and in communities;
• Advanced proficiency with Microsoft Excel, Word, Access, Outlook, Visio, Smartsheets and Adobe with the ability to adapt to a range of database applications;
• Previous phlebotomy training or certificate and/or willingness to be trained in phlebotomy;
• Collaborative Institutional Training Initiative (CITI) Training or knowledge of regulations regarding the use of human subjects in clinical trials, outcomes research, nursing research, and other research areas or equivalent combination of education, experience, and training;
• Certification from the Society of Clinical Research Associates (SOCRA), the Association of Clinical Research Professionals (ACRP) or CRA certification for Research Administration.

Please let us know if you were referred by a current Massey employee to ensure we honor our commitment to the Employee Referral Program.

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