Clinical Research Coordinator, CSRN

About the role

Unit: Massey Comprehensive Cancer Ctr MBU
Department: Massey Clinical Trials Office

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.

Clinical Research Coordinators support Principal Investigators (PI) in the day-to-day activities required for activation, execution, and management of clinical, patient-oriented research studies or protocols. Typical duties include assisting the PI in assessing study feasibility, determining participation eligibility, and establishing guidelines for clinical data collection; serving as patient/participant recruiters; and performing a variety of complex activities involved in the collection, compilation, and documentation of clinical research data. They may work independently or as a member of a team, under general supervision, resolving most standard issues independently and referring complex issues to an upper-level manager or the PI as appropriate. Clinical Research Coordinators typically report to a manager or director or may report to an administrator or PI. 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.

Responsibilities

• Responsible for 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
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols
• Engage in various forms of communication about the studies they are assisting
• Be directly responsible for study coordination of an assigned portfolio of oncology clinical research studies covering a variety of diseases and conditions
• Serve as an ongoing resource for providing information on clinical research protocols
• Assist in clean up any prior data discrepancies
• Assist with sample preparation, collection and processing as needed
• Comply with VCU Health’s (VCUH) clinical research clinical permissions table
• Responsible for screening and recruitment of research participants
• Responsible for coordination of protocol required visits and procedures
• Ensure compliance and adherence to clinical research protocols
• Ensure studies are audit ready
• Assigned to assist different teams based on resource needs
• Maintain documentation and collection of protocol required information
• Assist with data entry as needed
• Participate in monitoring and auditing visits as applicable
• 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

• Bachelor’s degree in health research and/or healthcare-related fields or equivalent combination of education, experience, and training
• At least 1 year of relevant experience
• Must be able to complete mandatory competencies and certifications required by VCU and VCU Health, 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

• 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
• Spanish speaking preferred

Benefits

• Comprehensive health benefits (Medical, Dental, Vision) for employees and eligible family members from the Commonwealth of Virginia, plus optional FSA
• Paid annual and holiday leave granted up front: 28 Vacation Days