Clinical Trial Associate
Clinical Development | San Francisco, Ca | Full Time
Overview of the Role
The Clinical Trial Associate will play a key role in ensuring alignment between organizational and clinical strategy, operational structure, formalized processes, and execution. The Clinical Trial Associate provides project support to one or more cross functional protocol teams to ensure that high quality deliverables are met within budget and timelines. Key to the success of this effort will be to support the planning and implementation of clinical trials conducted at one or more member institutions.
This individual will work closely with the clinical study team to ensure key projects are defined and implemented according to the organization’s strategic plan. Critical success factors are proactively lead and manage tasks for timely delivery. S/he will coordinate internal and external clinical communications, collate team discussions into actionable items, assemble various reports including dashboards, excel, meeting actions/agreements and analyses, and support long and short term goal setting and planning construction.
Reporting Structure and Team
The Clinical Trial Associate reports to the Sr. Director of Clinical Operations and is a key member of the Clinical Development team.
Essential Job Functions
- Provides logistical support to a clinical study team
- Develop, maintain and manage appropriate study documentation including eTMF filing and auditing for both internal and CRO files
- Collect, review and approve site regulatory documents. Work with Clinical Trial Manager and Regulatory for appropriate submission of essential documents
- Set up and maintain tracking systems and tools and report study metrics to support the clinical study
- Coordinate communication of tracking information within Study Team and to sites
- Manage and track clinical and non-clinical supplies
- Manage and track study-specific payments
- Coordinate investigator meeting planning, including preparing meeting materials and on-site meeting implementation; may present at investigator meetings
- Develop study related documents in collaboration with the study team, ensure site binder is set up or set up of electronic site binder per systems
- Assist with vendor management in collaboration with the Clinical Trial Manager
- Minute and lead action item facilitation for implementation meetings and study progress teleconferences
- Lead eTMF vendor interface, act as eTMF super-user and log-in delegate
- May have some clinical monitoring interface
Knowledge, Skills, and Experience
- Working knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects
- Bachelor’s degree, preferred Science or Nursing, MA/MS is a plus
- Experienced in supporting early development phase clinical trials, experience in immuno-oncology trials preferred
- Ability to work independently with minimal supervision and prioritize work deliverables to ensure the completion of essential deadlines
- Strong planning, communication, organizational and analytical skills
- Willingness to travel to site visits and relationship building
Introduction to the Organization
The Parker Institute for Cancer Immunotherapy (“PICI” or the “Parker Institute”) is a not-for-profit organization whose mission is to accelerate the development of immunological cures for cancer through innovative science, advanced technologies and new modes of research collaboration. The Institute is based in San Francisco, California and officially launched in April 2016.
To achieve its mission, PICI has established significant new cancer immunology research centers at six of the top cancer research and treatment institutions in the country (Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center), and will organize and support a portfolio of advanced, collaborative research efforts across this consortium.