Benefits: 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 benefits,
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.
- Continuing education for undergraduate and graduate tuition for
a maximum of 6 credits per semester;
Department: Massey Clinical Trials Office
Department Summary: 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
Clinical Data Managers generally perform administrative and study related duties that are essential to the successful management of research conducted by principal investigator(s) at the university. This position may support human subject research that is not conducted in a clinical or health care environment or does not require access to clinical facilities, systems, or data. Typical duties may include scheduling and monitoring of research activities and timelines; coordinating the management, storage, and reporting of study data; monitoring data to maintain quality control; and scheduling and booking monitoring visits. They 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. Clinical Data Managers typically report to a manager or director or may report to a department administrator. NOTE: 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.
This recruitment is open for three (3) separate Clinical Data Manager positions.
Job Description:
- 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
Minimum Qualifications
- High School Diploma or equivalent
- Must be able to complete mandatory competencies and certifications required by VCU and VCU H, 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.
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.
VCU is committed to hiring veterans! VCU will include a veteran’s period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!
Preferred Qualifications
- Bachelor’s degree or equivalent combination of training and experience preferred
- 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 preferred
- Spanish speaking preferred
Salary Range: Commensurate with experience, range minimum of $44000
FLSA Exemption Status: Non-Exempt
Restricted Position: No
ORP Eligible: No
Flexible Work Arrangement: Hybrid
University Job Title: 93406 - Open
Contact Email: masseyhr@vcu.edu