Clinical Research Coordinator Associate

Location
California, United States
Posted
Wednesday, 20 January 2021
End of advertisement period
Saturday, 20 March 2021
Ref
88162
Academic Discipline
Life sciences, Biological Sciences
Contract Type
Fixed Term
Hours
Full Time

This recruitment is for up to two (2) full time, fixed term (1 year) positions.

The Department of Pediatrics, Division of Critical Care Medicine is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of the Hair Biomarkers Study in preschool and schoolchildren. Incumbent will coordinate moderately complex aspects of one or more clinical studies and work under close direction of the Principal Investigator and/or Lab Manager/ supervisor.

Duties include:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies. 
  • Coordinate studies from startup through closeout.
  • Determine eligibility of and obtain informed consent from study participants according to protocol. 
  • Assist in developing recruitment strategies.
  • Collection of data from surveys, body measurement, study specimens (hair, possibly saliva), initial processing and storage.
  • Collect and manage patient and laboratory data for clinical research projects. 
  • Manage research project databases (REDCAP, Excel), 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:

  • Bachelor’s degree in scientific field (e.g. Biology, etc.)
  • Knowledge of REDCap database.

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.

KNOWLEDGE, SKILLS AND ABILITIES (DESIRABLE):

  • Time management skills and high efficiency in determining priorities, filing documents, organizing events to promote the study in approved sites, maintaining logs of samples and other study materials, promptly responding to parents and teachers.
  • Experience with research protocols and regulatory bodies, which include HIPAA regulation, Institutional Review Board requirements, and Good Clinical Practices.

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 Information

  • Schedule: Full-time
  • Job Code: 4924
  • Employee Status: Regular
  • Grade: F
  • Department URL: http://pediatrics.stanford.edu/
  • Requisition ID: 88162
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