Clinical Rsch Coord Assoc

Grade: F

FTE: 100%

This recruitment is for up to four (4) full time roles. Each position will be expected to work onsite at several locations in the following SF Bay Area counties: San Mateo, Santa Clara, Alameda or Contra Costa.

Stanford University is seeking a Clinical Research Coordinator Associate in the Department of Pediatrics, Division of Infectious Diseases to work with the Maldonado Lab. This position will perform duties related to the coordination of COVID-19 surveillance and vaccine clinical studies. Coordinate moderately complex aspects of one or more clinical studies. Work under close direction of the study investigators and/or study coordinator/supervisor.

Learn more about our lab here: http://med.stanford.edu/maldonadoepigroup.html.

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.
• 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 a science related field (e.g. biology).

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. Onsite COVID related studies
• Will be required to work within one (1) of four (4) bay area counties to support onsite centers.