Responsible for the day to day operations of assigned laboratory focus, providing general oversight, management and leadership for large scale multi-site research projects. Provide oversight for development and implementation of new research projects. Assure that good research practices are followed in the conduct of specific research projects by.Possess an in-depth knowledge of federal regulations and guidance documents for the conduct of research. Having the skills and ability to implement all aspects of focused research study protocols. Assuring compliance with protocol and regulatory requirements by having mechanisms in place for quality assurance and through the management of research staff and studies.Performs all responsibilities and duties in accordance with institution policy and procedures and the overall goals and objectives of Sanford Research. Responsible for overseeing data collection sites, compiling and analyzing data, writing reports, identifying funding sources and assisting with grant writing. Define scope of work, deliverables and timelines for various projects, will make decisions regarding allocation of personnel and other resources, budgetary responsibilities for cost centers, present findings and updates.Must possess ability to implement research protocol in the subject discipline with the ability to trouble shoot issues. Must possess knowledge of modern research methods, data collection and analysis. Must have significant experience in presenting and evaluating data. Ability to work collaboratively with a research group or team. General level of knowledge of project management, decision-making, and analytical skills. Strong verbal, written, and interpersonal communication skills. May have knowledge in more than one scientific area.
The Director will be responsible for day-to-day operations of the Clinical Research Project Management Office across the Sanford footprint, and will be charged with creating and maintaining investigator-initiated (IIR) policies and procedures. In addition, the Director will manage the IIR portfolio in oncology and non-oncology, along with associated workload/deliverables in alignment with institutional and departmental strategic plans. The Director will have primary oversight and provide direction to the project management, biostatistics, data management, and monitoring components of the department. The Director is responsible for ensuring all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state, and federal laws, regulations, guidance, policy and procedure developed by the Institutional Review Board (IRB), Food and Drug Administration (FDA), and Code of Federal Regulations (CFR).
Sanford Research is a multi-site institution and occasional local travel between sites may be required.
ACRP or SoCRA certification preferred. Bachelors degree required. Masters degree in related area preferred. Minimum of 5 years management experience preferred.
Req Number: req13236