Clinical Research Coordinator Associate

Location
California, United States
Posted
13 Aug 2019
End of advertisement period
13 Oct 2019
Ref
84293
Contract Type
Permanent
Hours
Full Time

The Department of Orthopaedic Surgery is seeking a talented and motivated Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies with the Total Joint Replacement Service. This position will be responsible for documenting research data, updating regulatory requirements, assisting with the recruitment strategies on two studies. The desired candidate is detail-oriented and conscientious, with excellent written and oral communication and interpersonal skills. To learn more about the Department please visit us at: https://ortho.stanford.edu/

The successful candidate will demonstrate:

  • Outstanding communication and relationship building skills;
  • Strong attention to detail, and competence to manage multiple priorities and respond effectively with limited guidance;
  • Commitment to uphold Stanford University’s compliance with federal, state, local, and sponsor regulation; and
  • Drive to establish themselves as a leading contributor within the Department of Orthopaedic Surgery and Stanford Medicine.

Duties include:

  • Serve as a 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

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, http://adminguide.stanford.edu.

Additional Information

Schedule: Full-time
Job Code: 4924
Employee Status: Regular
Grade: F
Department URL: http://ortho.stanford.edu
Requisition ID: 84293