Cancer Clinical Research Project Manager

Location
California, United States
Posted
28 Aug 2019
End of advertisement period
28 Oct 2019
Ref
84461
Contract Type
Permanent
Hours
Full Time

The Stanford Cancer Institute (SCI) is one of only 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the country. As a NCI-designated Comprehensive Cancer Center the SCI is a dynamic and stimulating place to work as it maintains the highest level of scientific rigor, institutional support and coordination for the complete range of cancer-related research, including basic, translational, clinical and population-based science. The SCI brings together faculty with cancer-relevant expertise from four Schools and over 30 departments throughout the University. The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our cancer center to translate research from the laboratory into the clinical setting. Given the SCI’s mission, breadth, and depth it employs ~275 staff members (inclusive of the CCTO) in a fast-paced environment with tremendous opportunities for our Clinical Research teams.

Stanford University is seeking a Cancer Clinical Research Project Manager to provide oversight for data management integrity and study start-up process across a cancer clinical research group. They will independently manage significant and key aspects of clinical research study data entry, data analysis, and training of team members for all aspects of data quality.

Duties include:

  • Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
  • Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
  • Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
  • Audit operations, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
  • Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
  • Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
  • Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.
  • Develop, implement and monitor systems to ensure the integrity of the research data.
  • Oversee the study start-up process for all observational and diagnostic clinical research studies to ensure the timeliness and feasibility.
  • Collaborate with the Clinical Research Group Leader, the Clinical Research Manager, and other key stakeholders to develop and maintain standard practices, implement trainings, and track relevant metrics.

* - Other duties may also be assigned

DESIRED  QUALIFICATIONS:

  • Knowledge of clinical trials data management and clinical quality management
  • Clinical knowledge in the field of Neuroendocrine Oncology
  • Knowledge of various projects and implementation strategies 

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Strong interpersonal skills
  • Proficiency with Microsoft Office and database applications.
  • Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
  • Knowledge of medical terminology. 

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver’s License.

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:

  • Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
  • May require extended or unusual work hours based on research requirements and business needs.

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: 4923
  • Employee Status: Regular
  • Grade: H
  • Department URL: http://cancer.stanford.edu/