Neuromuscular Clinical Research Coordinator Associate

Overview

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 are excited to work with patients and their families and meet the following requirements, we offer a collaborative team environment in the Neuromuscular Division of Neurology.

• 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. You will contribute to understanding and treatment of previously fatal neuromuscular disorders in a positive environment that supports learning and teamwork. The Neuromuscular Division is seeking a Clinical Research Coordinator Associate (CRCA) to coordinate the oversight and implementation of research protocols ensuring efficiency and regulatory compliance. This role will run a subset of the division’s industry-sponsored drug trials, including gene therapies, small molecule drug trials, and other projects addressing pediatric and adult neuromuscular conditions including ALS, spinal muscular atrophy, Duchenne muscular dystrophy, myotonic dystrophy, myasthenia gravis, and others.

Interested candidates should include a CV and Cover Letter addressing how education and experience relate to the position as described above.

• 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.

• 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.

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.

• Strong…