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Advertising Summary: Clinical operations provide disease working group support, study initiation oversight, patient screening, eligibility confirmation and enrollment, protocol activity management, study data collection, clinical research sample processing and preparation, and collaboration with all patient care teams to ensure study parameters are met.

Unit: Massey Comprehensive Cancer Ctr MBU

Department: Massey Central Admin

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

Duties & Responsibilities:

A Clinical Operations Manager is responsible for the daily administration of assigned Disease Working Group programs. Managers provide training, consultation, and leadership within a school, department, and business unit and ensure policy implementation and legal compliance. In consultation with senior leadership, they develop processes and implement new programs. They have a measurable impact within the Clinical Operations department and influence service delivery in the Clinical Trials Office within the Massey Comprehensive Cancer Center. Managers work under intermittent supervision, resolving routine issues independently reporting to the Assistant Director of Clinical Research Operations and Workforce Development.

Job duties include but are not limited to: 

• Maintain advanced understanding of clinical research management duties from study initiation to closeout;
• Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as required;
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols;
• Supervise, manage and lead team of research personnel to achieve goals and objectives;
• Provide ongoing mentoring, coaching, and development to research staff to manage highly complex research;
• Serve as an ongoing resource for providing information and expert advice on clinical research protocols;
• Allocate staff resources according to strategic priorities, and monitor the success and direction of team projects;
• Ensure compliance and adherence to clinical research protocols;
• Ensure studies are audit ready at all times;
• Conduct random quality checks of staff responsibilities;
• Collaborate with a group of cross functional peers and stakeholders with a variety of backgrounds and experiences;
• Track and monitor direct report workload and reassign resources as needed to support team needs;
• Manage performing and underperforming direct reports;
• Works closely with Assistant Director of Clinical Research Operations and Workforce Development as well the Principal Investigators (PIs) to ensure disease working group (DWG) needs are being met;
• Run DWG and PI oversight meetings;
• Assist in development of standard operating procedures (SOPs);
• Act as a point of escalation between the staff and other management personnel, internally and externally;
• Represent clinical operations in the validation process of beacon research treatment plans;
• Participate in the internal feasibility process;
• Update the clinical trials management system (CTMS), OnCore study start up task list with real time information regarding tasks;
• Escalate any studies that may be delayed in task completion that would impact desired time to activation metrics;
• Comply with VCU Health’s (VCUH) clinical research clinical permissions table;
• Participate in monitoring/auditing visits as needed;
• Assist team members with assigned work as needed based on resource needs;
• Follow VCU internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards with other duties as assigned.

Minimum Qualifications

• Bachelor's degree or equivalent applicable combination of training, education and experience;
• 3+ years of relevant experience supporting data management activities with an exposure to data processes and flow or equivalent combination of education, training, and experience with the ability to learn basic data entry, understand complex protocols and motivation to learn the foundation of at least one oncology disease area;
• 3+ years of experience with various clinical research or healthcare technologies including but not limited to: EDC software, XML, OnCore, EMR (Cerner or EPIC), RedCap, DEEP6A;
• Proven ability to supervise and lead a team;
• Excellent oral and written communication skills, attention to detail, and time management skills;
• Ability to set priorities, make timely decisions and meet deadlines while working on multiple projects;
• Ability to work collaboratively and cooperatively in a large and complex organization and in a fast-paced work environment
• Advanced proficiency with Microsoft Excel, Word, Access, Outlook, Visio, Smartsheets and Adobe with the ability to adapt to a range of database applications;
• Interest in working in a fast paced, demanding environment and adapt to changing client status, regulations and work environment;
• 3+ years' of demonstrated professional knowledge of medical, oncology, clinical research and/or disease working group terminology;
• Ability to complete mandatory competencies and certifications required by VCU and VCUH, individual clinical trials and the NIH Human Subjects Protection training as assigned;
• ​Ability to provide own transportation to meet with patients within the service area (Downtown Richmond, Stoney Point, etc.) and attend all meetings within service areas and at training locations.

Please note VCU is not able to provide ongoing visa sponsorship for this position.

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.

Please let us know if you were referred by a current Massey employee to ensure we honor our commitment to the Employee Referral Program.

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

• Master's degree or an equivalent combination of training & experience;
• Documented 1+years of professional supervisory experience;
• Certification from the Society of Clinical Research Associates (SOCRA), the Association of Clinical Research Professionals (ACRP) or CRA certification for Research Administration;
• Collaborative Institutional Training Initiative (CITI) Training or knowledge of regulations regarding the use of human subjects in clinical trials, outcomes research, nursing research, and other research areas or equivalent combination of education, experience, and training.

Salary Range: Commensurate with experience, range minimum of $65,000

Benefits: All full-time university staff are eligible for VCU’s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, 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.

FLSA Exemption Status: Exempt

Hours per Week: 40

Restricted Position: No

ORP Eligible: Yes

Flexible Work Arrangement: Hybrid

University Job Title: 93232 - Open

Contact Information: masseyhr@vcu.edu