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- Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
- Coordinate collection of study specimens and processing.
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- 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.
- Train and provide technical support for study participants on devices involved in the study.
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Clinical Research Coordinator Associate - Stanford, CA, United States - Stanford University
Description
Grade: F
FTE: 100%
The Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition, is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies within the Stanford Medicine Children's Health Center for Pediatric IBD and Celiac Disease. This is an exciting opportunity for a talented individual to contribute to groundbreaking research in the field of pediatric gastroenterology while working in a collaborative and supportive environment. Join us in making a real difference in the lives of young patients and advancing the science of pediatric IBD and celiac disease
The CRCA will coordinate complex aspects of multiple clinical studies and work under the general direction of multiple principal investigators and/or supervisor. The CRCA will support federal and non-federal clinical research studies including epidemiological and investigative work in support of clinical trials, clinical research or biomedical research focusing on "bench to bedside" technology. The primary work will include supporting pilot studies of Pediatric Gastroenterology faculty (from study start up to closure), as well as federally funded and industry-sponsored studies in the future. The CRCA will need to provide their own transportation with the ability to get to/from other off-site clinics. This position will be onsite and may require occasional evening and weekend hours.
Duties include:
* - Other duties may also be assigned
All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.
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 $31.73 to $36.54.
DESIRED QUALIFICATIONS:
· Fluent in Spanish (verbal and written).
· Bachelor's degree in a relevant field such as Biology, Health Sciences, Public Health, Nursing, or a related discipline.
· Minimum of 2-3 years of experience of related work experience.
· Strong organizational skills with the ability to manage multiple projects and deadlines.
· Excellent attention to detail and problem-solving abilities.
· Excellent communication skills, both written and verbal, with the ability to interact professionally with patients, families, healthcare providers, and research team members.
· Strong teamwork and collaboration skills, with the ability to work effectively in a multidisciplinary team environment.
· Passion for improving the lives of children with IBD and celiac disease through leading-edge research.
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 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 require being on-call and/or require weekend, evening, extended or unusual work hours based on research requirements and business needs.
· Position may require the employee to support studies that are conducted at off-site clinics (within a 50-mile radius of the main campus). Incumbent may need to provide own transportation with the ability to get to/from these off-site clinics.