Cancer Clinical Research Associate

Location
California, United States
Posted
02 Aug 2019
End of advertisement period
02 Oct 2019
Ref
84194
Contract Type
Permanent
Hours
Full Time

The Cancer Clinical Trials Office in the Stanford Cancer Institute, in Stanford University’s School of Medicine seeks a Clinical Research Associate to perform duties related to the coordination of clinical studies as part of the Radiation Oncology Clinical Research Team. This positon will focus on data entry for cooperative group studies (RTOG and NRG) in head and neck oncology, CNS and other disease sites as needed. Clinical research experience in radiation oncology is desired but not required. The ideal candidate will work seamlessly as a team with the head and neck CRC2, will work to ensure the safety and well-being of trial participants and will document related data per protocols and CCTO SOPs and guidelines. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.

Core duties include:

  • Ensure that all regulatory submissions for cooperative group study renewals and amendments are submitted to CTSU in a timely manner.
  • Collect data and complete study documents/case report forms for clinical research projects using STSU website, Medidata, Triad and occasionally OnCore. Manage research project data bases, develop flow sheets and other study related documents.
  • 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.
  • Serve as primary or secondary contact with, sponsors, and regulatory agencies.
  • Coordinate collection of study specimens and processing.
  • Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
  • 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.

DESIRED QUALIFICATIONS:

  • Knowledge of the principles of clinical research and federal regulations.
  • Familiarity with IRB guidelines and regulations.
  • Previous experience with clinical trials.
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

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://cancer.stanford.edu/
  • Requisition ID: 84194