Clinical Research Study Coordinator Career Ladder
How will we be classified? What criteria will be used? Who decides?
Each coordinator will use a REDCap survey tool to assist in finding the correct position on the new career ladder based on competency and job responsibility. The survey includes employee attestation to knowledge, skills, and abilities within their current role for eight competency domains. The responses are submitted to everyone’s manager/PI for confirmation or correction.
Will coordinators lacking certification be classified in different roles?
There is an initial 18-month grace period to earn certification. After that period, a coordinator will be reclassified to an appropriate title until certification is obtained. External new hires will be granted a similar grace period. Internal transfers, if a promotion, will require certification.
What is the salary impact?
Since the new career ladder establishes levels at a higher granularity, the complexity is too varied to state the impact at this time. These job titles will be accompanied by a salary setting model by which points are awarded for education, work experience, etc. aligned to a specific salary.
If a coordinator is classified in a lower than expected title, but their performance is very good, what can managers/PIs do for their coordinator?
The career ladder provides objective criteria for growth, so support the employee in developing the skills, knowledge, and abilities to meet competencies and position requirements for promotion.
What is the impact on benefits?
Your current rate of pay, vacation or PTO accrual rate, or benefits will not be impacted by your new title. In some cases, an employee currently classified as exempt may become non-exempt under the Fair Labor Standards Act (i.e., eligible for overtime pay). If this happens, it will not impact your previous vacation or PTO accrual.
Clinical Trials Support Office
What functions/processes will be centralized at the Clinical Trials Support Office & MICHR rather than managed at the support unit level?
The Clinical Trials Support Office and MICHR, in partnership with the Clinical Trials Subcommittee and informed by members of the research community, continue to develop tools, common standards, and performance metrics to assess all aspects of the Clinical Trials Transformation. Centralized functions will include:
- Establishing a clinical trials pathway in MICHR to support U-M faculty, especially early-career investigators, in the development of a high-quality protocol.
- Developing a clinical trials operations manual that defines U-M standard procedures for activating and conducting clinical trials.
- Providing training for faculty and study coordinators.
- Implementing the professionalization of the study coordinator role.
- Streamlining regulatory review and contracting.
- Implementing and maintaining an enterprise Clinical Trial Management System.
- Facilitating the identification of potential trial participants, as well as enabling providers to easily find active trials.
- Furthering recognition of clinical trials activity in the promotion and tenure process.
- Integrating the clinical and research experience for patients.
- Establishing and tracking key performance metrics that are publicly available to the UMMS research community.
- MICHR will continue to offer the following services to investigators: biostatistics, database development, data management, mentorship, recruitment planning, study monitoring, IND/IDE support, education, and the Michigan Clinical Research Unit, among others.
What are some of the challenges faced by investigators conducting clinical trials?
Nationally, the clinical trials enterprise faces substantial challenges, in part, due to:
- Increased complexity in research study design
- Regulatory complexity
- Inadequate funding mechanisms
- Globalization and outsourcing of trials to areas with lower research costs
- Lack of prestige allocated within the medical school setting to the conduct of clinical trials
- Delays and logistical problems associated with a fragmented clinical trials infrastructure and healthcare system
Overall, the clinical trials and regulatory landscapes are ever-evolving. The CTSO and CTSUs are here to help investigators navigate the rapidly changing clinical trial environment.
Should trials that are conducted at the Veterans Affairs Hospital be included in a unit of the CTSO?
Trials are run at both Michigan Medicine and the Veteran Affairs Hospital should be included in a Clinical Trials Support Office CTSU. Trials that are 100% run at the VA should be left out due to different financial management systems.
Clinical Trials Support Units
What if faculty prefer to leave their trials outside of a CTSU?
All new trials are now supported by a CTSU. Every faculty who intends to do trials past 2018 will need to have their trials processed by a CTSU. We encourage faculty to review the services offered by the CTSUs and to join one that best fits their needs. In the near future, IRB submission will require indication of CTSU and if none is selected, the IRB will re-direct faculty into a CTSU. We expect faculty will continue to learn about and see the benefits of the CTSUs and OnCore.
Can a faculty join more than one CTSU?
Yes, a faculty can join more than one CTSU if different trials have different research themes or unique needs.
What’s the funding source for the new support units?
The importance of this initiative is underscored by a commitment of up to $30M to ensure we have the capacity, infrastructure, and capabilities to improve our performance in this area. Dean Runge and the U-M Medical Group Practice (formerly Faculty Group Practice) have equally allocated funds to be used to make the recommendations of the Clinical Trials Task Force a reality.
Do CTSUs have the ability to support multi-center trials, including those which have international sites?
If our researcher is the PI coordinating the multicenter study, indeed, CTSUs will support those trials. The CTSUs have central teams to assist with a variety of aspects associated with a larger trial, such as complex calendar builds and regulatory compliance. MICHR and School of Public Health also have the expertise to provide support for data management and coordination, building eCRFs, etc. OnCore has the capability of managing multi-center trials.
How do we operationalize the cost as a researcher for CTSUs? How will the NIH's per subject payment model affect me?
The per subject payment model is quite similar to the industry trial model and our CTSU infrastructure is well suited for this model. We do not expect it will cost you more money to use the CTSUs, in fact, we hope our budget training and justification will facilitate cost savings. Even with top researchers, money is left on the table, so a better system will facilitate tracking of payment and making sure invoices are issued in a timely manner.
I understand OnCore has vast functionality, which of OnCore’s resources will be required for CTSUs, study teams, and staff members to use?
Use of the following tools are required: billing calendar (budget), tracking study visits, patients enrolled, and finance. OnCore offers many other functions that are optional.
What systems can OnCore integrate with and which systems will phase out?
OnCore has several automated interfaces to the Michigan Medicines’s electronic health record, MiChart, reducing duplication of effort and possibility of data entry error. The MiChart team and OnCore Support Team are working closely to finalize the implementation elements for the new integrated research billing workflow. Clinical Trials currently in MBECT will be migrated into OnCore. eResearch will continue to be the source of truth for IRB information entry, which will integrate with OnCore. REDCap will remain available, though OnCore will be used to manage clinical trials' administrative data.
Will OnCore be available to researchers’ trials that do not meet the NIH definition of a clinical trial?
At this point, we are prioritizing clinical trials and establishing best practices. PIs that want to use OnCore for clinical studies that are not clinical trials (such as registry or observational) should consult with the Medical Directors of the CTSU most relevant to their research.