- A Master's degree in public health or a closely related field involved and four (4) years administering and managing multi-center clinical trials and observational studies at a major university and/or comprehensive medical center;
- OR a Bachelor's degree with a minimum of six (6) years of pertinent research experience or an equivalent combination of education and research experience to total ten years.
- Experience writing grant proposals and budgeting.
- Experience working with Institutional Review Boards.
- Experience in a laboratory including bench work processing tissue or blood samples, shipping of samples, microscope work, and setting up and using record-keeping systems.
- Current or previous certification in lab safety.
- Demonstrated written and oral communication skills and problem-solving skills.
- Ability to travel to study centers each year.
- Ability to take initiative, prioritize workload, and work independently.
- Willingness to learn new software tools and processes.
- Supervisory experience.
General Overview and Purpose
This position will serve as the study manager of the data coordinating center for the Brennan-Lala Head-and-Neck Cancer Registry. The study will be conducted across five enrollment centers and in the Data and Coordinating Center. This position will design the overall plan for the project. Before enrollment and follow up, he/she will take the lead in developing the study's procedures and protocol and training study staff at the five centers. After enrollment and follow up begin, she/he will conduct regular conference calls involving center study coordinators to ensure compliance, troubleshoot procedures at study centers and data problems, visit each center at least once per year to audit case report forms and assess the center's procedures and general status and troubleshoot as needed. The Study Manager will ensure procedures and protocols are being followed at all sites and will resolve any associated issues.
Study design and procedure development (100% until study enrollment begins)
- Development and supervision of study methods and procedures including recruitment, study visits, case report forms, storage and shipping of samples to carry out the research project
- Train site PIs and study coordinators in all procedures
- Design the study database/web interface site to be used for entering study data and real-time online reports, such as enrollment, timing of expected subject visits, missing forms, missing data items on forms, data queries, and missing samples
Day-to-day management of the study operation (95% after study enrollment begins)
- Resolve questions and issues associated with study procedures, form completion, protocol (e.g., eligibility), and use of the Web interface.
- Meet weekly with all coordinating center staff, including the director, to discuss new problems, work out solutions, trouble shoot, etc.
- Conference call weekly (or more often as needed) with enrollment-site study coordinators to discuss and problem-solve regarding problems with recruitment, completing study forms, other difficulties with procedures.
- Work with database administrator and data quality-control technician to identify and resolve data-quality problems, e.g., by changing procedures or forms as needed.
- Visit to each enrollment site at least once per year to audit consent forms, audit paper forms versus the study database, meet local study staff and discuss and problem-solve in person.
- Record, investigate, and resolve protocol violations.
- Prepare reports for internal monitoring and quality assurance.
- Revise manual of procedures and case report forms as needed.
- Train new enrollment site staff as needed.
Prepare manuscripts and presentations. (5% while enrollment is ongoing, 100% after enrollment and data clean-up)
The Division of Biostatistics is a graduate and Ph.D. academic unit. Contained within is the Coordinating Centers for Biometric Research (CCBR). The CCBR has been the home for many
decades of the data and statistical coordinating centers for numerous large multicenter projects including trial networks. Numerous other smaller local, national, and international projects have also been undertaken by the CCBR. The CCBR's role in multicenter clinical trials is highly proactive. Statisticians and other staff within the CCBR take an active role as scientific collaborators in projects from their inception. Staff at the CCBR have wide expertise in clinical trial design, operations, regulatory issues, data management, monitoring and reporting, data analysis and presentation. Senior statisticians within the CCBR have extensive experience as members of data and safety monitoring boards as members of NIH review panels, study sections and site-visit teams for clinical projects. The Division also provides statistical support on a number of other major clinical research projects throughout the University.
Does this position require a background check?