Inside Higher Ed
Neuromuscular Clinical Research Coordinator Associate
Inside Higher Ed, Palo Alto, California, United States, 94306
Neuromuscular Clinical Research Coordinator Associate
Position to coordinate the oversight and implementation of research protocols within the Neuromuscular Division of Neurology at Stanford University.
Responsibilities
Serve as primary contact with research participants, sponsors, and regulatory agencies, coordinating studies from startup through close-out.
Determine eligibility of and gather consent from study participants according to protocol, and assist in developing recruitment strategies.
Coordinate collection of study specimens and processing.
Collect and manage patient and laboratory data, 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, and prepare regulatory submissions, ensuring 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, resolving 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.
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 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 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
Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.
Computational skills.
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 and Schedule Occasional evening and weekend hours; full‑time on site.
Compensation and Benefits Expected pay range $34.56 to $40.30 per hour; full‑time salary; comprehensive benefits package.
EEO Statement 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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Responsibilities
Serve as primary contact with research participants, sponsors, and regulatory agencies, coordinating studies from startup through close-out.
Determine eligibility of and gather consent from study participants according to protocol, and assist in developing recruitment strategies.
Coordinate collection of study specimens and processing.
Collect and manage patient and laboratory data, 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, and prepare regulatory submissions, ensuring 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, resolving 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.
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 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 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
Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.
Computational skills.
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 and Schedule Occasional evening and weekend hours; full‑time on site.
Compensation and Benefits Expected pay range $34.56 to $40.30 per hour; full‑time salary; comprehensive benefits package.
EEO Statement 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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