The NCI-designated Stanford Cancer Institute brings together faculty with cancer-relevant expertise from four Schools, the Cancer Prevention Institute of California and 30 departments throughout the University. The Scientific Review Committee (SRC) reporting under the Clinical Research Oversight Group (CROG) operates in accordance within the established National Cancer Institute (NCI) guidelines for its designated Cancer Centers; overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements. There are more than 250 clinical trials open to accrual at any time within the Cancer Institute. NCI and other regulatory standards are continually changing. This position requires a sound knowledge of federal, state and local regulations regarding the conduct of clinical trials, the informed consent process, and the protection of human research subjects.
The SRC Program Coordinator must employ technical knowledge of Cancer Institute clinical research and standard operating procedures in order to assure that the Clinical Research Oversight Group operates efficiently and is compliant with local and government requirements. The SRC Program Coordinator evaluates clinical trial submissions to ensure compliance with SCI policies and procedures. Utilizing clearly defined expectations and effective communication skills, this position works directly with investigators to strengthen the quality of their submissions and clarify discrepancies prior to committee review. All of this is part of the cancer centers mission to combat cancer, a disease that profoundly affects our society.
Independently prioritizes workload and performs a comprehensive review of all cancer related clinical research studies submitted to the SRC.
Conducts protocol submission reviews and renewals within the appropriate timelines and implements the operations of the SRC.
Incorporates knowledge of the principles of clinical trials design, including a basic knowledge of biostatistics in order to assess the readiness of research protocols for review by the SRC.
Conducts a thorough review of submission materials to ensure overall consistency and accuracy against the protocol.
Collaborates with researchers at all points throughout the review process to clarify discrepancies and improve the quality of the protocol submission.
Ensures scientific reviewers are assigned, and that review forms are complete 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 enrollment information 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 SRC process for areas of inefficiency, and proposes changes for improving processes, and upon approval incorporates changes into the 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 (IRB, RMG, and OSR), 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
Excellent record of time management and setting appropriate priorities.
Self-starter with ability to work independently but collaboratively; demonstrated ability to work independently and as part of a team; capable of establishing and maintaining effective working relationships with a range of individuals from a variety of departments, institutions and organizations; ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment.
Superior follow-up skills while exercising diplomacy and tact, in working with faculty, coordinators, and staff.
Knowledge of oncology and clinical research conduct.
Strong critical thinking skills.
Strong problem-solving abilities and multi-tasking capabilities.
Solution-oriented approach to issues.
Ability to work independently and as part of a team while being collaborative in resolving problems.
Ability to use tact and diplomacy to maintain effective working relationships.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelors degree and three years of related experience or a combination of relevant education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Excellent communication skills and superb attention to detail.
Experience with MS Office products and database applications required.
Excellent inter-personal skills and customer service focus is required.
Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB.
Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
Strong writing skills.
Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
Occasionally sit, use a telephone or write by hand.
Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
* - 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.
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
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 d...edicated 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, 9000 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 University is an equal opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.