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Neuromuscular Clinical Research Coordinator Associate

3 months ago

Stanford, United States Stanford University Full time

Stanford University's Neuromuscular Division of Neurology is seeking a Clinical Research Coordinator Associate (CRCA) to join a neuromuscular research team dedicated to understanding and treating neuromuscular disorders. The position will coordinate the oversight and implementation of research protocols assuring efficiency and regulatory compliance while also performing laboratory tasks combining basic molecular research with translational and clinical research. The CRCA will be responsible for running the division's neuromuscular research studies and industry-sponsored drug trials, and may include gene therapies, small molecule drug trials, longitudinal natural history studies, and other PI-initiated projects dealing with pediatric and adult neuromuscular conditions including ALS, spinal muscular atrophy, Duchenne muscular dystrophy, myotonic dystrophy, myasthenia gravis, and others. The position will include working with neuromuscular patients in clinic, educating them on Stanford neuromuscular research studies, consenting participants, and coordinating sample collections during clinic visits. The position can be a launching pad for careers in biomedical science and clinical research. These studies of devastating nerve and muscle disorders will primarily be conducted at the Stanford University Medical Center, and work will be under the supervision of the principal investigator, and director of clinical outcomes research and development.

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.

- Other duties may also be assigned.

DESIRED QUALIFICATIONS:

Excellent organization, communication and time management skills.


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.

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.

- 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:

  • 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, The expected pay range for this position is $31.73 to $36.54 per hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at
    . For all other inquiries, please submit a 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. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.