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Clinical Operations Lead

Virginia Commonwealth University
Virginia, United States
Salary Not Specified
Posted Date
Dec 10, 2021

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Position Type
Faculty Positions, Health & Medicine, Dentistry, Medicine, Other Health & Medicine, Pediatrics, Surgery
Employment Type
Full Time
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Massey Cancer Center is seeking applicants to fill 5 Clinical Operations Lead positions in the Clinical Trials Office. Reporting into the Assistance Director, Clinical Research Operations Unit, the Clinical Research Operations Lead for the Clinical Trials Office at Massey Cancer Center will be responsible for the planning, organizing, managing, and controlling the daily operations of Clinical Research Operations Team aligned with Disease Groups and ensures development is consistent with NCI Comprehensive Cancer Center designation.

The Clinical Research Operations Unit within the Massey Cancer Center Clinical Trials Office is organized as disease-focused teams that generally include a clinical research nurse coordinator (CRN), a clinical research associate (CRA) functioning as data manager/coordinator, and a clinical research coordinator (CRC). The disease-focused team structure facilitates interaction with physicians and patients and allows each team to develop clinical expertise in its respective area. Each team is responsible for gathering and maintaining updated participant data, as well as participating in the coordination of patient care during protocol therapy. Assures all program development related to clinical trials within the Cancer Clinical Trials Office follows the guidelines mandated by Federal and local requirements including FDA research regulations and the International Conference on Harmonization (ICH) Good Clinical Practices (GCPs) and the Virginia Commonwealth University Institutional Review Board.

Minimum Qualifications

• Advanced knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols
• Oncology knowledge as demonstrated by extensive licensed oncology nursing experience, oncology clinical trials experience or other commensurate work experience
• A bachelor’s degree or equivalent and 5 years clinical research experience.
• Possess strong decision-making skills and the ability to problem solve and troubleshoot issues
• Strong organizational skills with the ability to manage large volumes of information and ever-changing priorities
• High level of accuracy and attention to detail
• High level of comfort with technology and dynamic change
• Ability to plan work and coordinate multiple projects
• Ability to contribute to preparation and delivery of reports, trainings and SOPs or ability to mentor and train others
• Customer oriented and ability to work within, build and lead a team
• Ability to provide leadership and promote collaboration in a fluid and dynamic environment
• Possess exceptional time management and change management skills
• Ability to manage people, clinical trials and team in a highly dynamic environment
• Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.

Preferred Qualifications

Seven (7) years minimum of clinical research operations, development and management, preferred
Five (5) years or greater of experience managing a team of clinical research staff, or leading a team is preferred
Five(5) years or greater experience working in oncology clinical research with demonstrated progressive increase in responsibilities
Knowledge and/or experience with NCI CCSG expectations is preferred
SoCRA or ACRP certification, RN, PA NP and PharmD will add strength to the applicant’s role.

Salary Range: commensurate with experience

Position Details:

Department: Massey Cancer Center
Employment Type: UF - University Employee FT
Restricted Status: No
FTE: 100
Exemption Status: Exempt

Contact Information:

Contact Name: Massey HR

Contact Email:

Contact Phone:

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