Job Description
This is an exciting opportunity to join the Neuroscience Clinical Trials Team
in Neurology & Neurosurgery. This team runs clinical trials for a wide range
of disease areas including: Epilepsy, NeuorimmunologyMultiple Sclerosis,
Alzheimers, Autonomic Disorders, Device Neurosurgery, Stem Cell Neurosurgery,
Headache, Radiology, Parkinson’s and more!
The Clinical Research Coordinator Associate is responsible for the overall
management and implementation of an assigned set of multiple research
protocols assuring efficiency and regulatory compliance. These studies will be
conducted at the Stanford Hospital and Clinics. Heshe will work as part of a
clinical trials research team and report to various Principal Investigators
conducting clinical research. Responsibilities include preparation of initial
study documents for IRB submission in compliance with all local, state and
federal regulations; advise the IRB of amendment changes to the protocol and
complete annual protocol renewals. Recruit, screen, assist in the informed
consent process and enroll subjects in accordance with good clinical practice
guidelines. Collect, record and maintain complete data files using good
clinical practice in accordance to HIPAA regulations. Heshe participates in
data retrieval, reporting, and preparation of files and Case Report Forms for
the various studies. The successful candidate will interact with subjects by
scheduling diagnostic and research evaluation visits, perform study related
assessments including collection of blood samples, processing and shipment.
Maintain drug accountability, adequate study supplies and equipment. The
coordinator will oversee subject compliance to the study protocol, obtain
information from the study subject regarding any changes in their medications
or adverse events and promptly report the findings to physicians for
documentation in the subject’s medical record. Report all serious adverse
events promptly to investigators, sponsors and the IRB. Protect the rights,
safety and well-being of human subjects involved in the clinical trials.
- ***
- *Duties include*:**
- Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
- Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
- Coordinate collection of study specimens and processing.
- Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documentscase report forms.
- Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
- Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
- Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance andor management staff.
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- Participate in monitor visits and regulatory audits.
_* - Other duties may also be assigned._
**EDUCATION & EXPERIENCE (REQUIRED):**
Two year college degree and two years related work experience or a Bachelor’s
degree in a related field or an equivalent combination of related education
and relevant experience.
**KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):**
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- 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 lightfine 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:**
Occasional evening and weekend hours.
**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 Universitys Administrative Guide, <
- The expected pay range for this position is $31.84 to $37.79 per hour._
- 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
([
rewards](
rewards)) provides detailed information on Stanfords 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 at_
[email protected]. For all other inquiries, please
submit a[contact
form](
contact)._
_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._
Job Tags
Hourly pay, Full time, Work experience placement, Local area, Afternoon shift,