The Yale School of Medicine and Yale Center for Clinical Investigation (YCCI) is expanding its clinical research administration and clinical trials operations team. There are currently several exciting opportunities to join our staff and help direct Yale’s clinical research enterprise as it continues to grow. The Yale School of Medicine oversee thousands of studies annually. YCCI is the administrative hub for Yale’s Clinical and Translational Science Award (CTSA), providing support for research across Yale University, Yale Medicine, and the Yale New Haven Health System, which includes one of the largest hospitals in the nation.
YCCI Facts & Figures
- Supports more than 1,000 faculty members pursuing more than 2,500 therapeutic clinical trials annually.
- One of the first 12 centers funded by NIH Clinical and Translational Science Awards (CTSA) program, receiving approximately $157 million in federal funding since 2006.
- Clinical collaborations across the state with more than 1,400 practicing physicians at over 300 community practice sites across the state.
- Enabled a more than 950% increase in industry-funded clinical trials at Yale.
- Initiated recruitment campaigns with community partners (“Help Us Discover” Awareness, Clinical Research Recruitment Campaign) that drew approximately 28,000 participants (30% under-represented minorities) to clinical trials in fiscal year 2020.
- 159 YCCI scholars have been awarded $557 million in independent grants (approximately 76% from NIH), producing approximately 5,200 publications.
For more about YCCI see: https://medicine.yale.edu/ycci/ or our service units at: https://medicine.yale.edu/ycci/researchservices/supportservices/
We have a strong team with recognized expertise in clinical trials and we are currently expanding in a myriad of key clinical research areas.
This new unit was created to manage our more than 100 multicenter trials. Until recently, Yale’s multicenter trial management was decentralized; this is an opportune time to provide a centralized service center that will offer efficiency to investigators who don’t have resources to manage multicenter studies on their own. We are seeking team members to provide technical and regulatory expertise to research faculty and staff; hire and supervise multicenter project management staff; create policies for the unit; work with senior faculty and leadership; and travel around the country to lead studies.
- The monitoring unit supports investigator-sponsored clinical trials conducted at the Yale School of Medicine. This role is focused on monitoring of all study site activities from site feasibility through close out (via on-site and remote monitoring at participating sites across the U.S.) to ensure successful trial execution and compliance to protocol, applicable SOPs, ICH GCP and federal regulations. Frequent travel, beyond CT, is required.
- YCCI has increased its QA staff five-fold since 2008 and we are continuing to expand to add more resources. In this position, you will work directly and in collaboration with YCCI leadership, Yale School of Medicine departmental leaders, investigators, research staff, the Yale Human Research Protection Program and the IRB to facilitate the review the activities associated with human subject research in terms of safety, compliance, and integrity of clinical trials conducted at Yale and at collaborating institutions.
- YCCI needs Clinical Data Management (CDM) team members with industry experience to help us expand our capabilities including overseeing data standards development and validation activities. These roles will be focused on leading CDM activities for multiple multi-site projects to meet the CDM and IT needs of clinical research studies including overseeing testing activities, monitoring project timelines, and communicating with stakeholders. We have already built an impressive technology platform, and we need team members with the technical and data standards knowledge (CDISC SDTM, ADaM, define.xml, FHIR) to help us continue to innovate.
- In partnership with the Yale Center for Analytical Sciences (YCAS) YCCI has a group of over 40 statisticians, statistical programmers and data managers. In this position, you will work with the study team and senior biostatistician to execute the statistical plan. This includes working with data managers to design case report forms and data checking procedures, creating randomization schemes, designing and programming tables, listings and figures for interim and final analyses, conducting statistical analyses and developing standard SDTM and ADaM files for FDA submission.
- YCCI is seeking experienced research study coordinators to safely and efficiently implement and support research studies. As part of a team of research coordinators that works with investigators from across the medical campus, you will have the opportunity to utilize your skills on a wide variety of studies.
- Across Yale School of Medicine, regulatory affairs support is a growing need for the increasing research portfolio. Regulatory affairs staff proactively work collaboratively with investigators and key stakeholders within departments at YSM, as well as colleagues across the Yale research enterprise. These roles may include tracking regulatory activation milestones and timelines, promoting timely and compliant opening of new studies in addition to actively submitting and monitoring approvals, document creation, sponsor relationships, and overall study management from a regulatory perspective.
- We continue to grow to meet our research portfolio needs and additional opportunities in other key areas include: