Stanford University School of Medicine
Neuromuscular Clinical Research Coordinator Associate
Stanford University School of Medicine, Stanford, California, United States, 94305
Neuromuscular Clinical Research Coordinator Associate
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Neuromuscular Clinical Research Coordinator Associate
role at
Stanford University School of Medicine . Overview
The Neuromuscular Division of Neurology is seeking a Clinical Research Coordinator Associate (CRCA) to coordinate the oversight and implementation of research protocols, ensuring efficiency and regulatory compliance. The CRCA will coordinate a subset of the division’s industry-sponsored drug trials, which may include gene therapies, small molecule drug trials, and other projects dealing with pediatric and adult neuromuscular conditions including ALS, spinal muscular atrophy, Duchenne muscular dystrophy, myotonic dystrophy, myasthenia gravis, and others. There are opportunities for long-term growth within the team, or the position can be a launching pad for careers in biomedical science. These studies will be conducted at the Stanford University Medical Center. Interested candidates should include a CV and Cover Letter addressing how education and experience relate to the position as described above. Responsibilities
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. Determine eligibility of and obtain 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, 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; resolve billing issues in collaboration with finance/management staff. Interact with the principal investigator regularly to ensure 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
Experience with database, data management, FDA regulations, IRB requirements and the Stanford clinical research environment is highly desirable. Ability to work independently and as part of a multidisciplinary team. Ability to determine workload priorities to accomplish tasks, 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 motor skills. Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift/carry/push/pull objects up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift 40 pounds or more. Working Conditions
Occasional evening and weekend hours. General Standards
Interpersonal skills: Ability to work well with Stanford colleagues and clients and with external organizations. Promote culture of safety: Commitment to personal responsibility and safety; communicate safety concerns; practice safe behaviors. Subject to and expected to comply with applicable University policies and procedures. The expected pay range for this position is $34.56 to $40.30 per hour. Stanford provides pay ranges as a good-faith estimate of pay for a position. The final offer depends on factors such as responsibilities, qualifications, budget, internal equity, location, and external market pay. Stanford offers a comprehensive rewards package; details are discussed during the hiring process. 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.
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Join to apply for the
Neuromuscular Clinical Research Coordinator Associate
role at
Stanford University School of Medicine . Overview
The Neuromuscular Division of Neurology is seeking a Clinical Research Coordinator Associate (CRCA) to coordinate the oversight and implementation of research protocols, ensuring efficiency and regulatory compliance. The CRCA will coordinate a subset of the division’s industry-sponsored drug trials, which may include gene therapies, small molecule drug trials, and other projects dealing with pediatric and adult neuromuscular conditions including ALS, spinal muscular atrophy, Duchenne muscular dystrophy, myotonic dystrophy, myasthenia gravis, and others. There are opportunities for long-term growth within the team, or the position can be a launching pad for careers in biomedical science. These studies will be conducted at the Stanford University Medical Center. Interested candidates should include a CV and Cover Letter addressing how education and experience relate to the position as described above. Responsibilities
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. Determine eligibility of and obtain 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, 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; resolve billing issues in collaboration with finance/management staff. Interact with the principal investigator regularly to ensure 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
Experience with database, data management, FDA regulations, IRB requirements and the Stanford clinical research environment is highly desirable. Ability to work independently and as part of a multidisciplinary team. Ability to determine workload priorities to accomplish tasks, 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 motor skills. Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift/carry/push/pull objects up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift 40 pounds or more. Working Conditions
Occasional evening and weekend hours. General Standards
Interpersonal skills: Ability to work well with Stanford colleagues and clients and with external organizations. Promote culture of safety: Commitment to personal responsibility and safety; communicate safety concerns; practice safe behaviors. Subject to and expected to comply with applicable University policies and procedures. The expected pay range for this position is $34.56 to $40.30 per hour. Stanford provides pay ranges as a good-faith estimate of pay for a position. The final offer depends on factors such as responsibilities, qualifications, budget, internal equity, location, and external market pay. Stanford offers a comprehensive rewards package; details are discussed during the hiring process. 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.
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