Description
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
Working Conditions/Environment:
The work environment for this position will include an indoor office and a
medical research
environment. It may include some minor annoyances such as noise, temperature
variations, etc. The
incumbent may sustain posture in standing or seated position and may utilize a
computer terminal for
prolonged periods of time.
VA Onboarding Requirements:
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.