Cancer Clinical Research Coordinator 2 - EDD(Hybrid)

Cancer Clinical Research

Coordinator 2 – Early Drug

Development

Hybrid Work

Arrangement

The Stanford Cancer Institute (SCI)

is one of an elite number of National Cancer Institute-Designated

Comprehensive Cancer Centers in the country, and is a prominent,

dynamic, growing and complex Institute within the Stanford

University School of Medicine. The SCI actively works to build

synergies and collaborations among faculty with cancer-relevant

expertise from four Schools and over 30 departments across Stanford

University. We seek a Cancer Clinical Research Coordinator 2 to

help us enact our mission to reduce cancer mortality through

comprehensive programs of cancer research, treatment, education and

outreach. Given the SCI’s mission, breadth, and depth, it employs

over 320 staff members in a fast-paced, team-oriented, and

forward-thinking environment with tremendous opportunities for

personal and professional growth. The Cancer Clinical Trials Office

(CCTO) is an integral component of the Stanford Cancer Institute

since the vital work performed there enables our adult and

pediatric cancer centers to translate research from the laboratory

into the clinical setting. You will be working with an unparalleled

leading-edge community of faculty and staff who are fundamentally

changing the world of healthcare in the cancer arena.

Reporting to the Early Drug Development Clinical

Research Manager, the Cancer Clinical Research Coordinator 2 will

be conversant in the goals, mission and priorities of the

Institute, and utilize this knowledge to provide leadership within

the clinical research team. We are seeking candidates with

excellent organizational skills and attention to detail. Our staff

run toward challenges, and you will have a demonstrated history of

doing the same with a high degree of professionalism, initiative

and flexibility. The CRC2 will Independently manage significant and

key aspects of a large study or all aspects of a few smaller

research studies. Responsibilities include leading the coordination

and management of clinical trials within the early drug development

portfolio and working with both internal and external stakeholders

to accomplish clinical trial

objectives.

Duties

include

Oversee and

manage 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 and analyze

data.

Develop project schedules, targets,

measurements, and accountabilities, as assigned. Lead team meetings

and prepare / approve minutes.

Formally 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.

Hybrid work

agreement.

may also be

assigned.

EDUCATION

& 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 with

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.

CERTIFICATIONS

& LICENSES : Society of

Clinical Research Associates or Association of Clinical Research

Professionals certification is preferred.

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.

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.

WORK

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,

http : / / adminguide.stanford.edu.

The

expected pay range for this position is $86,248 to $100,158 per

annum.

Stanford University

provides pay ranges representing its good faith estimate of what

the university reasonably expects to pay for a position. The pay

offered to a selected candidate will be determined based on factors

such as (but not limited to) the scope and responsibilities of the

position, the qualifications of the selected candidate,

departmental budget availability, internal equity, geographic

location and external market pay for comparable

jobs.

At Stanford

University, base pay represents only one aspect of the

comprehensive rewards package. The Cardinal at Work website

(https : / / cardinalatwork.stanford.edu / benefits-rewards) provides

detailed information on Stanford’s extensive range of benefits and

rewards offered to employees. Specifics about the rewards package

for this position may be discussed during the hiring

process.

Consistent with its

obligations under the law, the University will provide reasonable

accommodations to applicants and employees with disabilities.

Applicants requiring a reasonable accommodation for any part of the

application or hiring process should contact Stanford University

Human Resources by submitting a contact

form.

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.

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.