This position will serve as a senior study coordinator and is an individual with advanced knowledge of the principles of scientific investigation and clinical trials, who is capable of in-depth understanding of the study protocols, and who is capable of making difficult decisions independently. The position will also serve as program manager and is directly responsible for overseeing a diverse portfolio of research activities for multiple studies. May include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository.
Essential Functions:
- Must be able to implement the integration of multiple complex programmatic activities.
- Database management: Enter data into computerized report forms: generate reports.
- Ensures appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts
- Generates reports for study team, supervisor, Institutional Review board (IRB), Research and Development Committee (R&D).
- Attend tumor board and pathology conferences
- Conduct study specific procedures including but not limited to:
- Determine patient eligibility for studies.\
- Attend pre-clinic meetings and provide subject health summaries.
- Consenting subjects for research studies.
- Generating subject correspondence.
- Requesting labs and procedures (under the supervision of principal investigator).
- Evaluate/triage Subject events and seek assistance for emergent issues.
- Able to work effectively and show in depth knowledge of programs required for NCIRE, SFVAHCS and UCSF (Committee on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.
- Work with industry sponsors, coordinating centers, and outside entities.
- Oversee preparation of new IRB applications; arrange paperwork for renewal of existing protocols; respond to IRB requests for revisions; and coordinate protocol changes with study sponsors.
- Responsible for contract generation, negotiation and approval.
- Exercise strong administration and research coordination.
- Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the IRB in a timely manner.
- Provide mentorship to junior coordinators and/or other support personnel.
- Assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs).
- Provide ongoing staff training, as needed to ensure compliance.
- Coordinate amendment updates and maintain study files.
- Ensure that documentation and storage of study files meets legal requirements.
- Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research.
- Ensure all CHR documents are up to date.
- Monitor research space allocation and facility needs and coordinate maintenance.
- Perform other related duties as assigned.
- Ph.D preferred; M.S. or MPH with 4+ years of experience, or Bachelor’s degree with at least 5+ years of research or a combination of education and experience.
- Prior experience in developing recruitment strategies in complex environments and differing patient pools.
- Previous experience and in-depth knowledge with clinical research, contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
- Project management and leadership skills.
- Excellent problem-solving ability and attention to detail.
- Excellent demonstrated interpersonal, verbal and written communication skills.
- Ability to operate effectively in a changing organizational and technological environment.
- Experience in creating/developing project plans.
- Ability to interpret and apply policies and regulations.
- Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets.
- Significant project and clinical trial management experience.
- Experience using database software, such as Excel, MS Access, FileMaker Pro.
- Certification of the Society of Clinical Research Associates or the Association of Clinical Research Professionals is preferred.
- Fluency in spreadsheet software; ability to develop complex spreadsheets.
- Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
- Experience with grant application procedures, personnel documentation, contract generation and subcontracting.
For more information about Northern California Institute for Research and Education (NCIRE) or to apply for this exciting opportunity, please visit us at www.ncire.org.
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Northern California Institute for Research and Education (NCIRE) is proud to be an Equal Opportunity Employer.
Per San Francisco's Fair Chance Ordinance, NCIRE - The Veterans Health Research Institute will consider qualified applicants with criminal histories
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