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Head of Research Operations

• Collaborate with study teams to ensure appropriate study conduct in all departments by providing oversight and training regarding study start-up, implementation, regulatory affairs, data quality assurance, reporting, budget, pharmacy, and lab issues.
• Develop and oversee updating of study management tools and standards (e.g., SOPs, manuals, databases, checklists, case report forms) to assure data integrity, regulatory compliance, and the consistent conduct of CIDRZ research.
• Prepare and review study related reports/presentations as necessary for study funders, Ministry of Health, and other interested parties.
• Supervise the submission and tracking of Research Ethics Committee, locally and internationally as may be necessary, Ministry of Health, and Zambian Medicines Regulatory Authority submissions and approvals, in collaboration with study teams and the regulatory department.
• Provide support and coordination in submission and follow up of required Material Transfer Agreements between CIDRZ and its research collaborators to ensure efficient and timely approvals from the Ministry.
• Support as needed research grant development – including scientific, administrative, logistical and financial planning aspects – by reviewing grant applications and providing input on which projects should be undertaken by the organization.
• Provides the necessary support to successfully assemble and submit grant applications to governmental and private donors, working with teams in Zambia, the US and other collaborators.
• Oversees coordination, supervision of study coordinators, research managers, and regulatory personnel.  Prepare Terms of Reference (TOR) and Performance Management Instruments (PMIs) for study personnel and assist in the hiring process and ongoing performance review.
• Identify research training needs and coordinate with the training department to ensure that appropriate courses are identified and mechanisms are in place for staff to access the required trainings
• Actively participate in problem solving with study teams and other relevant CIDRZ staff.

• Master’s Degree in Health related field
• Minimum of five years’ work experience in research management
• Detailed understanding of international and Zambian regulatory requirements for research
• Demonstrable experience in research management or coordination of clinical trials and research studies
• Record of successful mentorship/coaching abilities

Posted by Unknown at 8:09 AM

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