Clinical Research Coordinator 2
Company: Stanford University
Location: San Mateo
Posted on: January 19, 2023
Job Description:
Stanford University is seeking a Clinical Research Coordinator 2
to conduct clinical research and work independently on
progressively more complex projects/assignments. Independently
manage significant and key aspects of a large study or all aspects
of one or more small research studies.
Duties include:
- Oversee subject recruitment and study enrollment goals.
Determine effective strategies for promoting/recruiting research
participants and retaining participants in long-term clinical
trials.
- Oversee data management for research projects. Develop and
manage systems to organize, collect, report, and monitor data
collection. Extract, analyze, and interpret data.
- Develop project schedules, targets, measurements, and
accountabilities, as assigned. Lead team meetings and
prepare/approve minutes.
- Formally supervise, train, and/or mentor new staff or students,
as assigned, potentially including hiring, preparing or assisting
with the preparation of performance evaluations, and performing
related duties, in addition to instruction on project work.
- Audit operations, including laboratory procedures, to ensure
compliance with applicable regulations; provide leadership in
identifying and implementing corrective actions/processes. Monitor
Institutional Review Board submissions, and respond to requests and
questions.
- Collaborate with principal investigators and study sponsors,
monitor and report serious adverse events, and resolve study
queries.
- Provide leadership in determining, recommending, and
implementing improvements to policies/processes; define best
practices.
- Develop study budget with staff and principal investigator,
identifying standard of care versus study procedures. Track patient
and study specific milestones, and invoice sponsors according to
study contract.
- Ensure regulatory compliance. Regularly inspect study document
to ensure ongoing regulatory compliance.
- Work with principal investigator to ensure Investigational New
Drug applications are submitted to the FDA when applicable. Ensure
Institutional Review Board renewals are completed. The job duties
listed are typical examples of work performed by positions in this
job classification and are not designed to contain or be
interpreted as a comprehensive inventory of all duties, tasks, and
responsibilities. Specific duties and responsibilities may vary
depending on department or program needs without changing the
general nature and scope of the job or level of responsibility.
Employees may also perform other duties as assigned.
DESIRED QUALIFICATIONS:
- Proficiency in use of electronic data capture systems.
- Regulatory experience
- Supervisory experienceEDUCATION & EXPERIENCE (REQUIRED):
- Bachelor's degree in a related field and two years of
experience in clinical research, or an equivalent combination of
education and relevant experience.KNOWLEDGE, SKILLS AND ABILITIES
(REQUIRED):
- Strong interpersonal skills.
- Proficiency in Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing
bodies, which include HIPAA and FDA regulations, Institutional
Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.PHYSICAL REQUIREMENTS:
- Frequently stand, walk, twist, bend, stoop, squat and use fine
light/fine grasping.
- Occasionally sit, reach above shoulders, perform desk based
computer tasks, use a telephone and write by hand, lift, carry,
push, and pull objects that weigh up to 40 pounds.
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and
file paperwork or parts, rarely lift, carry, push, and pull objects
that weigh 40 pounds or more. Consistent with its obligations under
the law, the University will provide reasonable accommodation to
any employee with a disability who requires accommodation to
perform the essential functions of his or her job.
WORKING CONDITIONS:
- Position may at times require the employee to work with or be
in areas where hazardous materials and/or exposure to chemicals,
blood, body fluid or tissues and risk of exposure to contagious
diseases and infections.
- May require extended or unusual work hours based on research
requirements and business needs.WORKING STANDARDS:
- Interpersonal Skills: Demonstrates the ability to work well
with Stanford colleagues and clients and with external
organizations.
- Promote Culture of Safety: Demonstrates commitment to personal
responsibility and value for safety; communicates safety concerns;
uses and promotes safe behaviors based on training and lessons
learned.
- Subject to and expected to comply with all applicable
University policies and procedures, including but not limited to
the personnel policies and other policies found in the University's
Administrative Guide, .Why Stanford is for you
Imagine a world without search engines or social platforms.
Consider lives saved through first-ever organ transplants and
research to cure illnesses. Stanford University has revolutionized
the way we live and enrich the world. Supporting this mission is
our diverse and dedicated 17,000 staff. We seek talent driven to
impact the future of our legacy. Our culture and unique perks
empower you with:
- Freedom to grow. We offer career development programs, tuition
reimbursement, or audit a course. Join a TedTalk, film screening,
or listen to a renowned author or global leader speak.
- A caring culture. We provide superb retirement plans, generous
time-off, and family care resources.
- A healthier you. Climb our rock wall, or choose from hundreds
of health or fitness classes at our world-class exercise
facilities. We also provide excellent health care benefits.
- Discovery and fun. Stroll through historic sculptures, trails,
and museums.
- Enviable resources. Enjoy free commuter programs, ridesharing
incentives, discounts and more. Stanford is an equal employment
opportunity and affirmative action employer. All qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender identity,
national origin, disability, protected veteran status, or any other
characteristic protected by law.
As an organization that receives federal funding, Stanford
University has a COVID-19 vaccination requirement that will apply
to all university employees, including those working remotely in
the United States and applicable subcontractors. To learn more
about COVID policies and guidelines for Stanford University Staff,
please visit
Keywords: Stanford University, San Mateo , Clinical Research Coordinator 2, Healthcare , San Mateo, California
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