Stanford University’s Department of Dermatology is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies The CRCA will coordinate moderately complex aspects of one or more clinical studies and work under close direction of the principal investigator and/or manager/supervisor. The CRCA will support federal and non-federal clinical research studies including dermatological and investigative work in support of clinical trials, clinical research or biomedical research focusing on “bench to bedside” treatment.
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
Qualifications:
DESIRED QUALIFICATIONS:
- A Bachelor’s degree with an educational background in medicine and/or scientific field (biological sciences, social sciences, etc.)
- Three years of clinical research experience preferred.
- Clinical research project management experience.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Proven ability to work independently and take ownership of a project.
- Proven ability to work collaboratively and cooperatively in a team environment.
- Ability to work effectively in a fast-paced environment with multiple projects and timelines.
- Strong oral and written communication skills.
- Detail oriented with excellent organizational skills.
- Proficiency in using computers, software, and web-based applications in a previous administrative setting.
Fluency in Spanish is a plus.
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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.
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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.
*- 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. Infrequently, the CRCA may be required to work over the weekends in order to meet the clinical trial deadlines and/ or work on any other duties assigned.
This role is hybrid, though the coordinator should expect to be in person at the RWC campus three to four days per week to support the studies.
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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.
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The expected pay range for this position is $34.56 to $40.30 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 ( 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.
