Clinical Research Coordinator

Location
California, United States
Posted
14 Nov 2018
End of advertisement period
14 Jan 2019
Ref
81152
Contract Type
Permanent
Hours
Full Time

Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

Duties include: 

  • Oversee subject recruitment and study enrollment goals. 
  • Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
  • 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, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. 
  • Monitor Institutional Review Board submissions, and respond to requests and questions.
  • 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.
  • Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. 
  • Track patient and study specific milestones, and invoice sponsors according to study contract.
  • Ensure regulatory compliance. 
  • Regularly inspect study document to ensure ongoing regulatory compliance.
  • Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. 
  • Ensure Institutional Review Board renewals are completed.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS: 

  • The EPOCH Study Manager will need to work with many faculty and staff members from different disciplines to ensure completion of this large and complex study. 
  • Prior experience in managing studies with multiple projects, and in supervising staff, is desirable, particularly prior experience in studies of pregnancy, women’s health, or cardiovascular disease. 
  • Demonstrated ability to work well with Stanford colleagues and with external organizations is desirable. 
  • Prior experience with tools such as REDCap and Stanford’s Clinical Data Warehouse is desirable.

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 disease and infections.
  • May require extended or unusual work hours based on research requirements and business needs.