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Clinical Research Coordinator Associate

Employer
STANFORD UNIVERSITY
Location
California, United States
Salary
n/a
Closing date
19 Apr 2020

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Contract Type
Permanent

The Stanford Radiology Department is a world leader in medical imaging research, including magnetic resonance imaging (MRI) and molecular imaging with positron emission tomography (PET), PET/MR, PET/CT and Focused Ultrasound. MRI and PET are both widely used clinically for diagnosis of medical problems, including assessment bone health, brain injury, pain localization, tumor localization and therapy monitoring. We lead clinical research programs for early disease detection, diagnosis, and therapy monitoring. Our research teams are dedicated to advancing patient care through innovative imaging, including technology development and new chemistry/probe development for clinical research. 

This Clinical Research Coordinator Associate position is focused on coordinating clinical research studies, including gaining an understanding of study requirements, good clinical practice regarding human subjects research, as well as adhering to all safety requirements related to MR imaging in particular. The successful applicant will be organized, outgoing, an excellent communicator, and thorough in record keeping. He/she will frequently be the first point of contact for participants in a research study, will explain all aspects of the study to subjects, and will communicate any concerns that the subject has to and from the research team. Complete records of all subject enrollment will be critical, including kick-off meetings for study start-ups, setup and maintenance of appropriate subject databases and/or study notebooks. The tasks may also include handling of patient data, including deidentification for research purposes, reporting of subject enrollment, and assisting with publication or presentation of study results. The research assistant may also be responsible for collecting surgical specimens from the operating room for research studies. 

The Department of Radiology leads multiple research studies that involves a range of individuals including faculty, scientific staff, post-doctoral fellows and students. The ability to work within a team is essential. Overall, this position will allow tremendous exposure to the research that is performed in the department, as well as growth opportunities in the university.

Stanford University is seeking a Clinical Research Coordinator Associate to perform administrative support duties related to the collection of clinical data and/or the coordination of clinical studies. Work under the direction and supervision of Dr. Frederick T. Chin.

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 attention to details in data collections, strong written and oral communication skills.
  • General understanding of scientific theory and methods.
  • Ability to work with human study participants.
  • Effective oral and written communication skills.
  • Ability to work with human study participants.

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.

Additional WORKING CONDITIONS: 

  • Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
  • May require extended hours with supervisor approval.

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, http://adminguide.stanford.edu.

Additional Information

  • Schedule: Full-time
  • Job Code: 4924
  • Employee Status: Regular
  • Grade: F

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