Data and Safety Monitoring Committee Program Coordinator
Job Number: 86872
Data and Safety Monitoring Committee (DSMC) Program Coordinator
The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Data and Safety Monitoring Committee (DSMC) Program Coordinator to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach. Given the SCI's mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting. You will be working with an unparalleled leading-edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.
Reporting to Protocol Review and Monitoring System (PRMS) Manager, the DSMC Program Coordinator will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to ensure the data and safety monitoring committee operates efficiently, facilitates reviews of safety and monitoring reports and aides in communication with the various entities.
We are seeking candidates with excellent skills in communication, critical thinking and having a collaborative outlook Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative and flexibility. Responsibilities include coordinating the Data and Safety Monitoring Committee meetings, creating presentations and safety reports for the committee's review, assigning reviewers and communicating committees' decisions to the investigators.
Works collaboratively with clinical investigators, research staff and the committee to communicate findings that can lead to improved clinical trial performance and/or compliance.
Independently prioritizes workload and performs a comprehensive review of all cancer related clinical research study monitoring, audit and safety reports and responses to be reviewed by the DSMC, within the appropriate timelines and implements the operations of the DSMC.
Incorporates knowledge of the principles of clinical trials conduct, in order to assess the readiness of research protocol reports and other review documents for review by the DSMC.
Conducts a thorough review of submission materials to ensure overall consistency and accuracy.
Collaborates with researchers at all points throughout the review process to clarify discrepancies and improve the quality of the review.
Creates Serious Adverse Events (SAE) reports and protocol deviation reports for review by the DSMC.
Ensures qualified reviewers are assigned, prior to presentation to the full committee.
Ensures meeting materials are organized with the goal of enhancing review of information by the committee and aid in decision making.
Attends committee meetings, ensuring procedures are followed and that minutes of committee meetings are taken, reviewed, and stored in an organized manner.
Follows up on outstanding action items defined by the committee and ensure resolution.
Reviews the protocol and protocol statement of support to check for discrepancies, communicates these findings to study teams, resolves discrepancies before studies are assigned to a meeting agenda for full review.
Ensures accurate recording of DSMC reviews into the clinical trial management system (OnCore).
Communicates in a timely manner with leadership regarding significant or time sensitive issues that arise that my hinder processing of reviews.
Regularly evaluates DSMC process for areas of inefficiency, and proposes changes for improving processes, and upon approval incorporates changes into the Standard Operating Procedures (SOP).
Interacts regularly with Chairpersons, Principal Investigators, Stanford Cancer Institute leadership and administrative personnel to communicate committee decisions.
Identifies potential issue trends relating to submissions that may impact other groups such as the Institutional Review Board (IRB), Scientific Review Committee (SRC) and Quality, and communicates with research staff and other departments to develop a plan for resolution.
Co-authors committee decisions on responses to investigators, assures these are reviewed, signed by the Chairperson, and communicated promptly to the investigator, Cancer Clinical Trials Office, and the Stanford Institutional Review Board.
* - Other duties may also be assigned
Prior monitoring or auditing experience in clinical research
Strong knowledge of federal, state, and local regulations regarding the conduct of clinical trials, the informed consent process, and protection of human subjects.
Experience as a user of Microsoft Office products is strongly desired, as is familiarity with database usage and reporting tools.
Ability to prioritize multiple tasks and activities while employing a high level of accuracy, strong communication, and adept interpersonal skills.
Ability to work independently with minimal supervision.
Experience developing and delivering training.
Certification through a professional organization such as Regulatory Affairs Professional Society (RAPS) or The Society of Clinical Research Associates (SOCRA) preferred.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and three years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Demonstrated ability to prioritize own work and multi-task.
Demonstrated excellent organizational skills.
Demonstrated ability to take initiative and ownership of projects.
Ability to communicate effectively both orally and in writing.
Ability to routinely and independently exercise sound judgment in making decisions.
Demonstrated experience working independently and as part of a team.
Relevant subject matter knowledge.
Ability to direct the work of others, for jobs requiring supervision.
Rarely lift/carry/push/pull objects that weigh 11-20 pounds.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS:
Occasional evening and weekend hours.
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
Location: School of Medicine, Stanford, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 12000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford is an equal empl...oyment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.