The clinical research data manager is responsible for the
collection, entry and management of data for multiple projects from
multiple Sponsor sources including national, pharmaceutical and
Investigator-Initiated Sponsors. The incumbent will work 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. You will report to the Manager, Data
Management Core within Clinical Research Operations Unit of the
Clinical Trials Office at Massey Cancer Center.
The candidate at the Advanced level (CDM III) will perform the
duties listed with minimal supervision as well as serve to train
and mentor CDM II/I. You may manage biospecimen and observational
studies in partnership and with support from the Clinical
Operations Lead and Study Investigator. The CDM III may also serve
as a super user of the DEEP6Ai assisting designated disease
specific study teams to match trials to patient and patients to
trials. You may represent the operations team as a clinical
operation representative on Disease working Groups and aid in the
identification and recruitment of patients to treatment clinical
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.
Intermediate level (CDM II) will perform the following job
responsibilities under general supervision. The candidate at the
Assistant level (CDM I) will perform these responsibilities under
Minimum Hiring Standards
- Project Start-up: 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.
- Test electronic data capture to meet the needs of studies.
- Help with project management and planning for all aspects of
data collection and data processing for research
- Ensure trial visits, data for study participant tests and
samples are done per the study
schedule and entered in a timely fashion.
- Support the clinical study team coordinator/research nurse and
PI as appropriate.
- Study Conduct: Review and resolve data discrepancies with
electronic data check systems.
- Reconcile internal and external data sources and query and
resolve any issues identified. Maintain all data management
documentation following standard practice guidelines.
- Study Closure: Perform database close and locking
- Perform procedures for archiving research databases.
- Finalize data management study data and documentation.
- Other responsibilities include: Create and review standard
Salary Range: Commensurate with experience
Department: Massey Cancer Center, Clinical Trials Office
- Assistant level (CDM I): Requires 1+ years of experience in a
role that supports data management activities with an exposure to
data processes and flow or ability to learn basic data entry,
understand complex protocols and motivation to learn foundation of
at least one oncology disease area.
- Intermediate level (CDMII) : Requires an Associate’s degree and
1+ years of experience in data management in a regulatory compliant
environment with a working knowledge of data management processes,
data cleaning and flow.
- Advanced and Intermediate level: Experience with EDC software,
XML, onCore, eMR (Cerner or EPIC), RedCap, DEEP6Ai.
- Experience with Microsoft
- Excel, Microsoft Word, Visio, Smartsheet and Adobe.
- Ability to work as a team member and independently; analyze
problems in a logical and systematic manner; pay attention to and
accurately execute detailed tasks.
- Effective oral, written, and interpersonal communication
- Demonstrated experience working in and fostering a diverse
faculty, staff, and student environment or commitment to do so as a
staff member at VCU.
Employment Type: UF - University Employee FT
Restricted Status: No
Exemption Status: Non-exempt
University Title: Research Coordinator (34061)
Contact Name: Massey Human Resources
Contact Email: email@example.com