Under the direct supervision of the Senior Director, Clinical Research Services, the Senior Manager, Office for Clinical Protocol Development (OCPD) is responsible for the development, implementation, standardization, and coordination to support high quality COH investigator initiated research protocols and protocol related documents. The OCPD provides a central hub for COH investigators with regard to (a) provision of tools and templates for the research community, (b) provision of information (referrals and orientation sessions) to investigators and others regarding investigator initiated research, (c) provision of an array of clinical protocol development services, (e.g. protocol and consent document writing and editing, facilitating operational communications with industry partners and budget and contract analysts, shepherding research projects through the committee review process) (d) provision of study-specific electronic data capture design services and associated tools for investigator-initiated clinical research. All services focus on standardization and sensitivity to facilitate end-user needs, while also meeting the flexibility necessary to meet the large array of investigator research content. The OCPD Senior Manager, reports to and collaborates with the Senior Director, Clinical Research Services on a regular basis. To support COH investigators, the OCPD Director must also coordinate with other departments involved in the development and oversight and conduct of human subject research including the Clinical Trials Support Services, EPIC Content Administrators, Clinical Research Protections Office, Safety and Data Quality Office, Biostatistics and Research Informatics, Clinical Trials Office, and the Office of IND Development and Regulatory Affairs, Investigational Drug Services, and a variety of shared resources (e.g. Genomics core, Pharmacolocy core, Translational Research Lab) that provide services to researchers.
Key Responsibilities include:
Provide supervision and leadership and oversight to the Protocol Development Coordinators. Serve as resource for issues. Provide training and encourage ongoing educational opportunities.
Retain and develop high quality staff with excellent writing, problem solving skills, as well as experience related to protocol document requirements and research data requirements. Build relationships with internal stakeholders, including consulting with researchers, biostatisticians, case report form developers, and oversight committee staff. Works with various stakeholders to build consensus and navigate the COH culture to effect change. Maintain effective communication with supervisors, program leaders, faculty, managers and staff. Collaborates with Research Protections and Clinical Trials Office leadership to ensure adherence with scope of practice requirements and support of professional practice framework.
Quality Protocol Document Development
Leverage subject matter expertise across the array of clinical research areas, which include repository development, biospecimen and questionnaire research, the use of FDA regulated imaging, to interventional research ranging from first in man agents and devices created at COH, repurposing established agents, and using applying current agents in specific ways. Ensure alignment with various COH departmental policies and procedures, including but not limited to IDSA, CTO, Pathology, as well as COH community practices, affiliates, research partnerships. Work with internal stakeholders to ensure the COH protocol template and tools for protocol development are cutting-edge and meet the NIH and FDA requirements as well as industry standards. Advise the Senior Director, Clinical Research Services and professional staff on issues related to relevant NIH and other Federal regulations, policies and guidance.
Case Report Form Development
Work with CRF developers and COH Investigators on the development of all case report forms for COH initiated trials. Working with investigators and biostatisticians, ensure that data to support primary objectives and endpoints are included. Working with Safety and Data Quality Office and Clinical Trials Office leadership, develop systematic and industry best practice approaches to case report form development to support quality control and monitoring efforts while improving efficiency of data entry.
As needed, liaise with industry partners for Industry Supported Trials (IST), to coordinate the protocol development and sponsor approvals, while ensuring relevant COH departments are kept apprised of progress. Where needed, assist in the development of LOIs and protocol concepts to help secure external/internal funding. Serve as a resource and subject matter expert, when needed, to the COH internal funding committees.
Metrics and Reporting
Develop metrics and regular reporting for workload volume, measures for protocol quality and related document, as well as other reports as needed or requested. Distribute and publish reports to senior leadership on a regular basis. Align to industry best practices and promote quality development of research consistent with NIH guidelines. Create and disseminate OCPD performance summaries, scorecards, and dashboards to facilitate ongoing quality and performance improvement initiatives. Design, implement, and monitor the impact of new templates, tools, policies and improved processes
In-services and orientations
Conduct and/or coordinate in-services with investigators, CTO staff, disease teams and by invitation conduct workshops. Conduct targeted training upon request to support protocol and case report form development.
By invitation from various organizations, give talks, lectures, and conduct workshops at national conferences, such as SoCRA, PRIM&R, and AACI.
Minimum Education and Skills Required for Consideration:
- Bachelors or higher degree in science or research related field. Experience and demonstrated subject matter expertise may substitute for minimum education requirements.
- At least seven years of progressive clinical protocol development and conduct of clinical research experience in a large, complex organization.
- Experience working with industry-partners on investigator initiated trials, especially with variety of clinical trial designs, including Phase 1 designs and IND development/communications.
- Experience working with quality of life and specimen collection research, as well as the design of electronic data capture forms.
- Working knowledge of policies and procedures that govern clinical research and research subjects protection, including but not limited to US Federal Regulations, International Committee on Harmonization - Good Clinical Practices, Health Insurance Portability and Accountability Act (HIPAA), National Cancer Institute Cancer Center Support Grants (NCI CCSG) requirements and National Institutes of Health requirements.
- Knowledge of Medicare coverage analyses and clinical trials budgeting and federal guidelines/regulations pertaining to clinical research.
- Strong management/supervisory principles.
- Knowledge and experience in designing/developing clinical trials, regulatory guidelines and requirements for the conduct of clinical trials.
- Knowledge and experience in the clinical research environment in a health care setting.
- Broad knowledge of medical terminology.
- Requires superior analytical, leadership, interpersonal, communication and presentation skills.
- Strong ability to anticipate end-user needs, and strong ability to develop systems, tools, and language to meet downstream end-user needs.
- Proficiency in MS Office Suite; ability to quickly learn and use advanced software functionality
- Ability to independently communicate and present at the executive level delivering a comprehensive demonstration of the understanding of investigator initiated research.
Preferred Education and Skills:
- Graduate degree(s) preferred