Clinical Data Manager

Virginia Commonwealth University•Richmond, VA

2d•Hybrid

About The Position

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. The role requires maintaining an established portfolio-driven knowledge base of federal and state laws and regulations, sponsor guidance, as well as university policies and compliance notices, with the ability to consistently interpret and apply accurately.

Requirements

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

Nice To Haves

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

Responsibilities

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
Scheduling and monitoring of research activities and timelines
Coordinating the management, storage, and reporting of study data
Monitoring data to maintain quality control
Scheduling and booking monitoring visits

Benefits

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
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
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
Employee Assistance Program
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!