Clinical Research Specialist

At Stanford University School of Medicine the work we do touches lives today and tomorrow. Through education, research , and healthcare, the School of Medicine improves health through leadership, diversity , collaborative discoveries, and innovation. Whether working in departments with faculty , or in units that support the school , our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health. The department of Pediatrics at Stanford University is seeking a Clinical Research Coordinator Associate (CRC2) to conduct clinical research and work on complex projects / assignments . This interesting and unique opportunity will oversee the clinical research functions of a multi-site pediatric oncology consortium. Pediatric Oncology Experimental Therapeutics Consortium Research Development and Management Center (POETIC RDMC) is a phase I clinical trial consortium whose mission is "To promote early clinical development of promising therapies for children, adolescents , and young adults with cancer and related disorders". This position will oversee significant and key aspects of the consortium large research studies and work under close direction of the principal investigator and / or study 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.
• 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.
• Participate in monitor visits and regulatory audits.
• 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 $84,856.00 to 97,021.00 annually DESIRED QUALIFICATIONS :
• Bachelor's degree in related medical field.
• Experience working with oncology clinical research studies.
• 1-2 years of experience in a clinical research setting is highly desirable . 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.