Cancer Clinical Research Coordinator Associate

Location
California, United States
Posted
18 Nov 2020
End of advertisement period
16 Feb 2021
Ref
87796
Contract Type
Permanent
Hours
Full Time

The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Clinical Research Coordinator Associate to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach. Given the SCI’s mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting.  You will be working with an unparalleled leading edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena. 

Reporting to Clinical Research Manager, the CRCA will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to implement all processes related to running a clinical trial with support from CRC2’s and their manager. We are seeking candidates with excellent organizational, communication (oral and written) and interpersonal skills.  Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative and flexibility. Responsibilities include all aspects of running a clinical trial including, but not limited to, regulatory submissions, new study start up, consenting, eligibility confirmation, enrollment and data collection.  As this is an entry level role, these activities will all be supervised by other members of the radiation oncology team and the CRM until they are proficient at the tasks assigned to them. 

Core duties include:

  • Ensure that all regulatory submissions for cooperative group study renewals and amendments are submitted to CTSU in a timely manner.
  • Review and collect source documents enabling the completion of study documents/case report forms for clinical research projects using STSU website, OnCore, RedCap, iMedidata, and Triad. Manage research project databases, utilize team 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. Be able to identify and report study deviations. 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.

* - Other duties may also be assigned

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):

  • Highly detail oriented
  • Comfortable reading medical charts and data entry
  • 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: 87796

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