Research Associate

School of Medicine

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Duke University Job Description\Department of Medicine

Division of Infectious Disease

Job Title: Research Associate Level 1

Job Summary

Dr. Thuy Le, MD, PhD, is looking for a curious, motivated junior researcher to join her team as a Research Associate / Clinical Trial Coordinator Level I. Candidates with background in epidemiology/public health is required, and an interest in infectious diseases clinical trials and global health is preferred but not a requirement. The junior researcher will be working primarily as a coordinator of several clinical studies to advance the diagnosis and treatment of major invasive fungal infections affecting patients with advanced HIV disease in Southeast Asia, including talaromycosis and histoplasmosis.

As a Research Associate and Trial Coordinator, the individual will assist the PI with study start up tasks, including clinical protocol development, development of the clinical trial manual of operations, prepare protocols for ethical approval, develop SOPs, study training materials, coordinate/set agenda/report minutes at weekly team meetings and monthly trial leadership meetings. The individual will have the opportunity to travel to Vietnam, Thailand, and China to clinical sites with PI, and serves as the point of contact for site PIs and site study staff. They will ideally have fundamental knowledge of clinical trial design and operation, and will work along PI with lots of guidance and support.

This is an exciting opportunity for a new graduate with a master degree in epidemiology / public health / biostatistics to emerge themselves in a highly interdisciplinary team science environment combining laboratory development and testing of novel diagnostics, pre-clinical evaluation of novel therapeutic strategies, to diagnostic and therapeutic clinical trials. The individual will have the opportunity to develop themselves in clinical research skills, and is highly encouraged to further develop their quantitative skills with the potential to lead / co-lead research projects from designing studies to data acquisition, data analysis, data visualization, and publications as first or co-first authors of papers.

The individual will be closely mentored by Dr. Le, as well as a senior statistician working on clinical trials and various projects. The individual will have the wider support of research-oriented activities in the Division of Infectious Disease, Duke University Department of Medicine, as well as in the Duke Department of Biostatistics and Bioinformatics. The individual is expected to lead weekly clinical trial meetings, and is willing to meet on zoom once weekly in the evenings with research teams in Asia. The individual will have weekly one-on-one meetings with Dr. Le to receive a high level of mentorship.

Specific tasks

• Participate in site selection and in training site personnel regarding the trial; perform site monitoring duties and follow up to ensure identified deficiencies are corrected; travel as required inside and outside of the USA to accomplish responsibilities.
• Participate in the development of protocols, informed consent forms, case report forms (CRFS) and instructions, site selection materials, procedure/in service manuals, project newsletter, project specific standard operatingprocedures, and other monitoring tools for the clinical trial.
• Follow established guidelines in the collection of clinical data and/or administration of clinical trials.
• Assist in assessing the suitability of potential investigative sites through telephone screening interviews, regulatory document review and disseminating clinical trial information; conduct site qualification visits to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of principal investigator to conduct and complete the planned clinical study.
• Conduct site initiation visits as needed for the purpose of training site personnel about the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, case report form completion and retention requirements, drug accountability procedures, and serious adverse events (SAES) , reporting procedures, and overall management.
• Conduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFS, source documents, medical records, and regulatory documents; provide feedback to assigned sites and information regarding detected deficiencies and corrective action needed.
• Follow up with sites until deficiencies are resolved.
• Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Interested individuals are encouraged to contact Dr. Le with any further queries before and during the application process at thuy.le@duke.edu

Minimum Qualifications

Education

See job description for education requirements.

Experience

See job description for requirements.

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