Clinical Trials Design & Management: Jobs
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Cancer Clinical Trials Office Research Administrator for The Stanford Cancer Institute
Posted June 18, 2019
Cancer Clinical Trials Office Research Administrator 3
The Stanford Cancer Institute (SCI) is one of only 49 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the country. As a NCI-designated Comprehensive Cancer Center the SCI is a dynamic and stimulating place to work as it maintains the highest level of scientific rigor, institutional support and coordination for the complete range of cancer-related research, including basic, translational, clinical and population-based science. The SCI brings together faculty with cancer-relevant expertise from four Schools and over 30 departments throughout the University. The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our cancer center to translate research from the laboratory into the clinical setting. Given the SCI's mission, breadth, and depth it employs ~275 staff members (inclusive of the CCTO) in a fast-paced environment with tremendous opportunities for our Clinical Research teams.
The Stanford University NCI Designated Cancer Clinical Trials Office seeks a Research Administrator. This position will report to the Cancer Clinical Trials Office (CCTO) Financial Manager. The Research Administrator is the Institutional Representative for sponsored cancer clinical trials and is the primary point of contact for sponsor and University clinical research grant and contract administrators. Working in collaboration with faculty, business managers and other departments, hospital and University staff, the Research Administrator directs and manages the clinical trial proposal and award process to ensure timely, compliant and accurate contracts. This includes protocol review and interpretation, interpretation and application of pertinent government regulations and guidelines, develops budgets, negotiates and provides strategic advice to the PI, ensuring that the contract budgets and payment schedules/terms meets sponsor, University, hospital and School pre-and post- award guidelines/regulations. The Research Administrator accepts the budget on behalf of the Cancer Center, provides expert consultation and oversight to ensure that sponsored research funds are managed and expended in compliance with internal and external policies, and continues as the institutional representative throughout the life of the award.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and five years of job related experience, or combination of education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Expert knowledge and fluency of governmental regulations (e.g. FAR, A-21, A-110, A-133, CAS).
- Knowledge and ability to understand, interpret, and communicate university policies and procedures.
- Excellent oral, written, and communication skills.
- Excellent analytical skills; demonstrated proficiency in Excel and web-based tools.
- Strong accounting skills; knowledge of accounting principles.
- Knowledge of procurement needs, including sole-sourcing, cost analyses, vendor requirements, and small business reporting.
- Strong knowledge of property management requirements related to Stanford or non-Stanford title of equipment and fabrications.
- Expert in project management, including managing international collaborations and complex multi-sub award contracts.
- Knowledge of personnel management, including proposing effort for and training and hiring of students, post-doctorals, academic appointments, regular staff, bargaining unit staff, and consultants, along with the circumstances appropriate for each type of position.
- Extreme attention to detail.
- Ability to review a proposal or manage a project with understanding of the overall scope and goal of each sponsored project.
- Excellent time management and organizational skills.
CERTIFICATIONS & LICENSES:
- Cardinal Curriculum I and II must be completed to remain in this position.
- Certified Accountant or Auditor, MBA, project management certification, or similar credential desired.
- Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push and pull objects weighing up to ten pounds.
- Occasionally stand, walk, grasp forcefully, use a telephone, write by hand and sort and file paperwork or parts.
- Rarely lift, carry, push and pull objects weighing 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.
- 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 Stanford University Administrative Guide.
- Schedule: Full-time
- Job Code: 4483
- Employee Status: Regular
- Grade: I
- Department URL: The Stanford Cancer Institute
- Requisition ID: 83529
Clinical Trial Assistant for Tricida
Posted May 24, 2019
Clinical Trial Assistant
We seek a highly motivated Clinical Trial Assistant (CTA) to join our team supporting management of Tricida-sponsored clinical trials. The primary focus of this in-house CTA position is to provide administrative and project specific support related to the conduct of clinical trials and archiving of clinical trial documents, including assistance with project management activities, performing administrative duties required to run the clinical program.
Assist in coordination and planning of study management process.
Facilitate flow and maintenance of correspondence with contract service providers.
Participate in internal and external team meetings.
Setup and coordinate meetings, prepare and distribute meeting materials and meeting minutes.
Setup and maintain trial master file and tracking tools.
Assist in contacting investigative sites to provide study-specific information.
Assist with preparation, tracking and distribution of presentation materials.
Assist in review and development of clinical study documents and tools.
Assist in clinical trial supplies management and distribution.
Assist with collection of regulatory/essential documents.
Assist with review of clinical study data and documents for quality control purposes.
Prepare clinical study newsletters.
Provide administrative support.
Perform other tasks as assigned by manager.
Experience & Skills:
Education: Bachelors degree in the scientific or healthcare field is preferred.
Experience: 2+ years of relevant work experience in the pharmaceutical industry.
Skills and Capabilities: Knowledge of medical terminology is preferred. Proficiency in Microsoft Office suite is required.
Knowledge and understanding of ICH/GCP guidelines and FDA regulations is required.
Ability to work independently and initiative are required.
Excellent verbal and written communication skills to interact in a team oriented environment are required.
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, stock options, 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday. Tricida is located in South San Francisco, CA.
To be discussed with HR.
Jaruwan Taylor, Senior Clinical Research Associate (email@example.com): please ask applicants to apply directly to the link below; and include a cover letter. Thank you.
Employer City / Location:
South San Francisco
Tricida, Inc., is a pharmaceutical company focused on the development and commercialization of its drug candidate, TRC101, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). Metabolic acidosis is a chronic condition commonly caused by CKD that is believed to accelerate the progression of CKD, increase the risk of muscle wasting and cause the loss of bone density.