Position Type : Full Time
This position will report to the Principal Investigator of a specific disease site(s) and will also work closely with the Lead Nurse for the group, if one has been designated. The successful candidate will work closely with disease group investigators to oversee all aspects of the research being performed within their group. This includes assisting with study selection, prioritization of the team’s work, working closely with the Regulatory Manager to manage, review and initiate trials. Project Managers are expected to actively manage ongoing research projects, troubleshoot operational issues on a daily basis and assist with any and all aspects of their team’s work during absences or when a specific team member’s workload exceeds capacity (including, but not limited to, managing patient visits, transporting specimens, data entry, query resolution and working with study monitors).
Specific responsibilities include (but are not limited to):
* Working with disease site physician investigator leaders to ensure balanced staff workload, select and optimize study portfolio for currently available resources, anticipate any need for a disease group to hire additional staff based on data analysis and develop a business proposal to reflect any needs
* Submitting complete Initial and Amendment study packets and logistical review forms to regulatory, along with appropriate study contacts
* Performing group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572’s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications.
* Communicating any specialized study budget needs to the budget specialist, including any changes necessitated by a protocol modification and assisting the financial department by working with the study team to provide study visit information and invoiceable items as needed
* Work closely with the Regulatory Manager of the CRU to manage review and startup of trials
* Working with team members to ensure accurate and timely data entry into Velos (our electronic Clinical Trials Management System), including study status, screening logs, serious adverse events and subject enrollment status
* Closely monitoring and reporting to their team the status of all studies within their group, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing any issues
* Conducting weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and other issues needing to be addressed
* Monitoring staff workload and work with other disease teams and Administrative Director to share or borrow staff when needed and appropriate. This will include management of staff paid time off.
* Attending disease group meetings, site initiation visits, and (as needed) monitoring visits.
The candidate will work closely with the CRU Administrative Director to develop and implement SOP’s, report team study metrics and communicate issues that may affect overall research with CRU Trials. The Research Manager may also have primary study coordinator responsibility for at least 1 study.