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Children's Hospital of The King's Daughters · 19 hours ago

Director, Clinical & Research Operations

Norfolk, VA

Full-time

Onsite

Lead/Staff, Director/Executive

5+ years exp

Children's Hospital of The King's Daughters is seeking a Director of Clinical & Research Operations to oversee all clinical operations related to research study projects. This role involves collaboration with researchers and administrative staff to ensure the effective management of clinical trials and adherence to regulatory standards.

ChildrenHealth CareHospital

Responsibilities

Determine administrative feasibility of new protocols

Implement pre-initiation activities such as establishing timelines for conducting and completing clinical trials, clarifying protocol issues with sponsors, acting as a liaison between the Clinical Research Institute and study sponsors, and making initial contact with potential PIs and/or sub-investigators to collaborate on projects

Maintain up-to-date knowledge of regulatory requirements and GCP standards

Coordinate with the Director of Clinical Research Administration to prepare and submit documentation to the institutional review board and other committees as required

Ensure regulatory staff make timely administrative submissions to the IRB and other committees as appropriate

Assist pediatric and faculty and other research staff with regulatory submissions by reviewing, guiding, and providing required documents

Facilitate and attend meetings regularly to discuss updates, issues, and/or concerns regarding projects

Oversee all clinical functions related to research activities

Provide coordination of space and equipment required by clinical trial activities

Supervise Clinical Research Associates (CRC) and Clinical Research Coordinator (CRA) in components related to recruitment study, visits, and documentation

Monitor enrollment goals and perform administrative tasks arising from the PI’s recruitment plan

Assist CRCs/CRAs with problem-solving/form development as needed in the conduct of clinical trials

Coordinate with Laboratory and Pharmacy staff regarding requirements of clinical research activities

Develop, implement, and maintain quality assurance standards and measures

Keep informed of current trends in clinical research and regulatory requirements

Maintain a customer-focused environment for providers and consumers to monitor feedback

Investigate and respond timely to all customer complaints

Assist with preparation of study budgets

Maintain communication regarding study status and expenses

Work with the financial manager on study-related issues

Supervise orientation and training on new CRCs and other study staff

Provide staff with clear expectations of service levels

Leads, manages, coaches, and trains a team or department, provides guidance, support, and mentors to ensure optimal performance and productivity

Oversees the recruitment, hiring, team/department orientation, performance appraisals and disciplinary actions including up to termination processes for a team or department

Performs all other duties as assigned

Qualification

Clinical research operationsRegulatory complianceLeadership experienceHealthcare administrationQuality assuranceVerbal skillsWritten skills

Required

Bachelor's degree in healthcare administration or a health related or business-related field is required

Three years of health care experience required

Three years of management experience required

Five years of progressive leadership experience in research administration required

Demonstrated professional knowledge of areas of research and practice administration

Excellent verbal and written skills

Company

Children's Hospital of The King's Daughters

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Children’s Hospital of The King’s Daughter’s (CHKD) Health System operates Virginia’s only freestanding, full-service children’s hospital and its pediatric practices, multi-service health centers, and urgent cares throughout southeastern Virginia and northeastern North Carolina.

Founded in 1961

Norfolk, Virginia, USA

1001-5000 employees