Job description
Stanford University is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies. Work under close direction of the principal investigator and/or study coordinator/supervisor.
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 documents/case 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 and/or 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
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. The pay range for this position working in the California Bay area is between $56,000 to $78,000 based on commensurate experience and background.
DESIRED QUALIFICATIONS:
- 1 year of experience in clinical research, preferably in pediatrics
- Bachelor’s degree in health/medical field (e.g., Biology, Human Physiology, etc.)
- Fluent in writing and/or speaking Spanish strongly preferred.
- Knowledge of interpretation of clinical work strongly preferred.
- Strong background in clinical trials research, screening and recruitment of potential participants, identification, and communication of adverse health effects
- Must have ability to navigate EMRs, collaborate with healthcare team and coordinate clinical trials, demonstrated ability to work effectively within a moderately autonomous environment in addition to having a complete commitment to achieving goals in a timely manner.
- Must be flexible, dependable, and able to handle multiple priorities with conflicting deadlines.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in a related field and one year 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. May require a valid California Driver’s License.
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.
Additional PHYSICAL REQUIREMENTS: (remove if none)
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 disease and infections.
May require extended or unusual work hours based on research requirements and business needs.
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