Cancer Clinical Research Associate Stanford University - School of Medicine United States

Cancer Clinical Research Associate


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 position focused primarily on Investigator Initiated Trials (IITs) in thoracic oncology, GU oncology, cooperative group trials and other disease sites as needed. Clinical research experience in radiation oncology is desired but not required. This position will be focused primarily on data management, supporting a CRC2. Strong skills in Microsoft office is essential. Initially, the incumbent will work with the team to ensure the accuracy of data entry. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health. A good candidate will be a self-starter, motivated and able to work well in a partnership with a CRC2.

 


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.

 


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.


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