Staff Research Associate I
NCIRE - The Northern California Institute for Research and Education, Inc. · CA, US
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About the Role
The Staff Research Associate I participates in the day-to-day operations of routine, minimally complex clinical research programs and/or studies. This role performs administrative and operational duties for data collection, compilation, documentation, and review, supporting research objectives under close supervision. The position supports new and ongoing research projects on the Hematology Oncology Research Team, focusing on precision oncology.
Responsibilities
- Prepares and participates in site initiation, monitoring, and closeout visits.
- Manages document storage activities and related training.
- Assembles necessary parties to ensure required agreements are in place.
- Utilizes electronic data capture systems, technologies, and software for research operations.
- Scores tests, enters data, and completes required forms accurately according to protocol.
- Assists with the development of data collection documents and instruments.
- Maintains subject level documentation.
- Prepares documents, equipment, and/or supplies.
- Identifies issues and recommends solutions.
- Consents patients for non-interventional research studies.
- Interviews patients.
- Generates patient correspondence.
- Submits assigned studies for review and approval and provides status updates.
- Assists the regulatory team with Institutional Review Board (IRB) preparation and submission.
- Screens, schedules, and consents participants in assigned clinical research programs/studies.
- Explains the difference between clinical activities and research activities, and risks and benefits of study participation to participants.
- Engages with the senior study team to maintain participant recruitment and retention rates.
- Assists participants with individual needs and collects information to determine feasibility.
- Collects information to determine feasibility, recruitment, and retention strategies.
- Collects, prepares, processes, ships, and maintains inventory of research specimens.
- Trains in developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs), and Case Report Forms (CRFs).
- Conducts and documents visits and testing/interviews according to all assigned regulatory and organizational protocols.
- Trains in completing and submitting AE reports according to institution and sponsor-specific reporting requirements.
- Assists with the development of proposals or protocols as directed.
- Identifies and communicates related shortcomings.
- Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.
- Maintains compliance with institutional requirements and policies.
- Develops and maintains familiarity with the ethical conduct of research and safeguards needed when conducting clinical research.
- Trains in the design of safeguards to ensure ethical conduct and to protect vulnerable populations.
- Participates in sponsor-required training.
- Trains on professional guidelines and code of ethics.
- Proactively includes others in decision making and escalates issues to leadership as necessary.
- Learns various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program/study aims.
- Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness.
- Recognizes and reports vulnerabilities related to security of physical and electronic data.
- Assists with recognizing trends related to data quality and escalates as appropriate.
- Adheres to and participates in the development and assessment of quality assurance.
- Assists with identifying issues related to operational efficiency and shares results with team members.
Requirements
- Prior experience with research in the hard sciences, clinical sciences, or social sciences, including prior academic research experience.
- Ability to work independently as well as part of a team.
- Ability to manage multiple tasks and priorities to achieve desired goals.
Skills
- Strong oral/written communication skills
- Strong interpersonal skills
- Strong organizational skills
- Experience with word processing software
- Experience with database software
- Proficiency in conducting literature searches
- Strong attention to detail
Location
- San Francisco VA
Work Type
- Onsite
- Indoor office
- Medical research environment
Experience Level
- Staff Research Associate I
- Minimally complex clinical research programs
Education Level
- B.A. / B.S.
Salary/Compensations
- $24.11-$28.87 per hour
About the Company
- NCIRE is an affiliate organization of the San Francisco VA Health Care System (SFVAHCS).
- NCIRE offers career opportunities in research and administration in pursuit of furthering medical research for our nation’s Veterans.
Equal Opportunity
- The Northern California Institute for Research and Education (NCIRE) is an Equal Employment Opportunity Employer.
- NCIRE is committed to a policy that provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, religion, national origin, ancestry, age, marital status, medical condition, physical or mental disability, Veteran status, sexual orientation, or any other characteristic protected under federal and state law, and to make all employment decisions based on merit, qualifications, and abilities.
- We are committed to furthering the principle of equal employment opportunity.
- NCIRE actively works to attract and retain talented individuals.