Clinical Research Coordinator Associate

Location
California, United States
Posted
09 Jan 2019
End of advertisement period
09 Mar 2019
Ref
81490
Contract Type
Permanent
Hours
Full Time

The Department of Medicine, Division of Oncology is seeking an exceptional, highly motivated and team oriented full-time Clinical Research Coordinator Associate (CRCA). The work of the Division of Oncology bridges the worlds of basic science, clinical diagnosis and the treatment of cancer. Our basic investigative activities concentrate on immunology, genetics/genomics, pharmacology, DNA repair and oncogene action. Our clinical science covers each cancer type; has a strong focus in clinical trials of new diagnostic and therapeutic approaches, and in correlative laboratory studies. Our work is supported by a portfolio of peer-reviewed grants, industrial agreements and research endowments.

The CRCA will perform duties related to the coordination of health services clinical studies focusing on improving clinical cancer care delivery under the supervision of Dr. Manali Patel’s research activities.  The CRCA will support the PI by coordinating moderately complex aspects of Dr. Patel’s ongoing clinical studies and work under close direction of the principal investigator /supervisor. The CRCA will serve as primary contact with research participants, sponsors, and regulatory agencies and coordinate studies from start-up through closeout. S/he will assist with IRB protocols, managing large data sets and protocols. The CRCA will support the preparation of various protocols, proposals, and manuscripts.

Duties include:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies.  Coordinate studies from startup through closeout.
  • 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.
  • 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.
  • Help prepare manuscripts and reports, including preparing tables and formatting references. 
  • Other duties may also be assigned

DESIRED QUALIFICATIONS:

  • Master’s degree in public health or related field.
  • Previous experience working on issues related to health services intervention trials in oncology.  
  • History of work in school settings.
  • Interest in working in a position for at least two (2) years.  
  • Understanding of statistics and familiarity with STATA or similar data analysis software
  • Ability to drive and transport needed to travel to school which are not easily accessible via public transportation from Stanford

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.
  • Ability to drive to off-site locations for study recruitment and data collection.
  • Strong oral and written communications skills.

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.