Clinical Data Manager

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

Preferred

• 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
• 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

Benefits

• All full-time university staff are eligible for VCU’s robust benefits package, including 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, and 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, and 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, and Employee Assistance Program.
• Hybrid work arrangement.
• One revolutionary idea. One promising clinical trial. One new breakthrough.
• Richmond, Virginia, USA
• https://www.masseycancercenter.org
• Growth Stage
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• Michelle Lin
• Chief Administrative Officer (CAO)
• Ocelia Hudson
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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
• 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 VCU is not able to provide ongoing visa sponsorship for this position
• 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
• 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

Required skills

• ACRP Certification, CITI Human Subjects Protection Certification, Clinical Practice (GCP), Clinical Research Administration Certification, Human Subjects Protection, Oncology Clinical Research, SOCRA Certification

Preferred skills

• Previous experience in oncology clinical research preferred

Experience

• Mid level