Neuromuscular Clinical Research Coordinator Associate

Stanford University School of Medicine; Palo Alto (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Stanford University School of Medicine’s Neuromuscular Division seeks a clinic Clinical Research Coordinator Associate (CRCA) to coordinate oversight and implementation of research protocols, ensuring efficiency and regulatory compliance on clinic days.

The CRCA serves as primary research liaison with participants, providers, and external teams, and may manage investigator-initiated trials including gene therapies and drug trials.

Qualifications

• 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.
• Experience with database, data management, FDA regulations, IRB requirements and the Stanford clinical research environment desirable.
• Ability to work independently and as part of a multidisciplinary team.
• Strong communication and organizational skills; attention to detail.

Responsibilities

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
• 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 IRB 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.

Tools

Microsoft Office

Electronic Data Capture (EDC)

Job description

Job Description

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?

• 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.

Job Description

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?

• 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.
• 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 clinic Clinical Research Coordinator Associate (CRCA) to coordinate the oversight and implementation of research protocols assuring efficiency and regulatory compliance. The CRCA will serve as the primary research liaison on clinic days, collaborating closely with participants, providers, and external teams. Additionally, the CRCA will be responsible for managing a subset of the neuromuscular division's investigator initiated trials. These 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 of devastating nerve and muscle disorders will be conducted at the Stanford University Medical Center. Interested candidates should include a CV and Cover Letter addressing how your education and experience relates to the position described above.

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.

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

Occasional evening and weekend hours.

WORK STANDARDS (from JDL)

• 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, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu .

Responsibilities

Core Duties

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
• 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.

Minimum Education And 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.

Certificates And Licenses Required

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Qualifications

Drivers License Requirements

• Must possess and maintain a valid California non-commercial Class C Driver's License.
• Ability to drive day or night.
• When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.