Neuromuscular Clinical Research Coordinator Associate

Do you want to help Stanford University better understand and measure the effects of neuromuscular disorders, including: muscular dystrophies, spinal muscular atrophy, amyotrophic lateral sclerosis, inherited neuropathies, and other conditions? If you enjoy working directly with patients and their families, are excited to work with patients affected by neuromuscular disorders, are exceptionally organized, have excellent time management, can work independently, and are a proven quick learner. Enjoy working directly with patients and their families. Are excited to work with patients affected by neuromuscular disorders. Are exceptionally organized and can balance multiple projects at one time. Have excellent time management and can meet deadlines. Can work independently. Are a proven quick learner. Then we offer the opportunity to work in a collaborative team of neuromuscular investigators, contribute to understanding and treatment of previously fatal neuromuscular disorders, and an exciting and positive environment. The opportunity to work in a collaborative team of neuromuscular investigators. The chance to contribute to understanding and treatment of previously fatal neuromuscular disorders. Exciting and positive environment where you will always learn new things. Teamwork and camaraderie. Competitive full time salary. Excellent Stanford benefits. The Neuromuscular Division of Neurology is seeking a Clinical Research Coordinator Associate (CRCA) to coordinate the oversight and implementation of research protocols assuring efficiency and regulatory compliance. The CRCA will be responsible for running a subset of the neuromuscular division’s industry-sponsored drug 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 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. DESIRED QUALIFICATIONS: Experience with database, data management, FDA regulations, IRB requirements and the Stanford clinical research environment highly desirable. Ability to work both independently and as part of a multidisciplinary team. Ability to determine workload priorities in an appropriate way to accomplish tasks and goals, meet deadlines and anticipate and solve potential problems. Experience with patients or research subjects. Strong general computer skills and ability to quickly learn and master computer programs. Good oral and written communication skills to effectively work with physicians, clinical staff and other health care professionals. Proficiency with Microsoft Office, Word, Excel and various industry-oriented electronic data capture programs. Excellent organizational skills and attention to detail in maintaining accurate, retrievable records. 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. Computational Skills. 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. 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. Stanford University 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.

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