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Clinical Research Coordinator

3 months ago

Stanford, California, United States Stanford University Full time

The Stanford University Department of Orthopaedic Surgery in the Division of Pediatric Orthopaedic Surgery is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of various clinical studies and data-driven projects related to spinal surgery and scoliosis outcomes. This position coordinates moderately complex aspects of the clinical studies and works under close direction of the research manager and Principal Investigator. The ideal candidate will serve as the primary point of contact for the study participants and be motivated to support a cohesive and mission driven team of faculty and staff that are advancing the field of Orthopaedic Surgery. To learn more about the Department please visit us at:

The successful candidate will demonstrate:

  • Excellent communication and relationship building skills;
  • Strong attention to detail and commitment to uphold regulatory compliance; and
  • Drive to establish themselves as a leading contributor within the Department of Orthopaedic Surgery.

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:

  • Bachelors Degree in biology, chemistry, public health or other health-related field.
  • 1-2 years working in clinical research.
  • Ability to work fast and efficiently within time constraints.
  • Ability to work independently and comfortably with study participants.
  • Prior data entry and management experience.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelors degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • General knowledge of medical terminology.
  • Ability to work with human study participants as well as in a team.
  • Attention to detail in data collection and excellent organizational skills.
  • Ability to work under deadlines with general guidance.
  • Strong written and oral communication skills.
  • General computer skills and ability to quickly learn and master computer programs such as REDCap, Microsoft Office.
  • Ability to interpret, adapt, and apply guidelines and procedures.

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 ) provides detailed information on Stanfords extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

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 by submitting a contact form.

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.

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