Staff Research Associate I

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.

NCIRE is an affiliate organization of the San Francisco VA Health Care System (SFVAHCS), which requires all candidates to complete SFVA onboarding in addition to NCIRE's onboarding process. The SFVA is a federal agency that requires a federal background check, occupational health clearance, vaccines and immunizations, and drug testing for certain positions. Drug testing may include screening for marijuana which remains an illegal substance according to federal law.  The failure to pass required drug testing will disqualify candidates from employment.

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.