Staff Research Associate I

Position Definition:

The Staff Research Associate I is responsible for participating in the day-to-day operations of routine, minimally complex clinical research programs and/or studies conducted by Principal Investigators (PIs) at the San Francisco VA. Performs a variety of administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data. Supports the achievement of research program and/or study objectives. Works under close supervision, receiving instruction, guidance and direction from Senior staff research associates, Clinical Research Supervisor and/or leadership team.

We are looking for a professional, team-motivated, detail-oriented individual to provide support for both new and ongoing research projects on the Hematology Oncology Research Team here at the SFVA! These projects encompass industry and/or PI-initiated studies focusing on precision oncology.

Essential Functions:

An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions which the employee may be expected to perform.

• Documentation/Data Collection- Prepares and takes part in site initiation, monitoring, closeout visits, document storage activities, and related training. May assemble the necessary parties to ensure that all required agreements are in place. Utilizes and assists senior team members on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations. Scores tests, enters data, and completes required forms accurately and according to protocol. Assists with the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies identifies issues recommends solutions.
• Conduct study specific procedures including but not limited to:
• Consenting patients for non-interventional research studies
• Interviewing patients
• Generating patient correspondence
• Regulatory- Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.
• Study Participation- Screens, schedules, consents participants in assigned clinical research programs and/or studies. With guidance, explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Engages with senior study team to maintain participant recruitment and retention rates and assists with participants with individual needs, collects information to determine feasibility. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens.
• Protocol- 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.
• Human Subject Research Protection- Maintains compliance with institutional requirements and policies. Develops and maintains a 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 and participates in sponsor required training. Trains on professional guidelines and code of ethics.
• Team Coordination- 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 and/or study aims.
• Quality Assurance- Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. 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.

Job Requirements:

• B.A. / B.S.
• Prior experience with research in the hard sciences, clinical sciences, or social sciences, including prior academic research experience, e.g. college-level research
• Strong oral/written communication, interpersonal and organizational skills
• Experience with word processing and database software, such as Microsoft Access and Excel
• Proficiency in conducting literature searches
• Ability to work independently as well as part of a team
• Ability to manage multiple tasks and priorities to achieve desired goals
• Excellent organizational skills
• Strong attention to detail

The base salary range for this position is $24.11-$28.87 per hour. The base salary actually offered to a successful candidate will take into account various relevant and non-discriminatory business factors including, without limitation, the candidate's geographic location, job-related experience, knowledge, and skills, and education, as well as internal equity considerations. A successful candidate may also be eligible to earn additional compensation including bonuses.

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. NCIRE offers career opportunities in research and administration in pursuit of furthering medical research for our nation's Veterans.