Clinical Data Manager

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.

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

Qualifications:

Minimum Qualifications

• High School Diploma or equivalent
• Must be able to complete mandatory competencies and certifications required by VCU and VCUH, individual clinical trials and the NIH Human Subjects Protection training

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;
• 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.

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.