Date Posted: Feb 28, 2018
Application Deadline: Open Until Filled
Clinical Research Associate
Western University Campus - Pomona, CA
6006-WesternU Center for Innovation
Type of Position
Exercise independent judgment in performing all responsibilities as delegated by University Research administration and individual Principal Investigators. The primary focus will be on contract studies or investigator-initiated industry sponsored studies performing tasks under only general supervision. Secondary focus will be on faculty initiated studies and/or student studies that may or may not be funded externally.
Knowledge, Skills and Abilities
Individuals must possess these knowledge, skills and abilities or be able to explain and demonstrate that the individual can perform the essential functions of the job, with or without reasonable accommodation.
Ability to work well with co-workers, peers, monitors and potential subjects
Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adhere to sponsor requirements
Strict attention to detail and strong organization skills.
The candidate should be able to promote a teamwork philosophy with a positive attitude and able to work under only supervision.
• BA/BS in a Health Sciences discipline
• 2+ years clinical research experience.
• Excellent phlebotomy skills
• Bilingual (English and Spanish)
• Masters degree preferred
• 5+ years clinical research experience
• Background in medical history intake and medical terminology preferred
List comments regarding work hours
Monday to Friday; willing to work weekends when necessary.
Essential Job Duties
• Organize and prioritize all activities associated with conducting the studies assigned to him/her.
• Review and understand protocol, ensuring applicable regulations and guidelines are followed
• Oversee and assure that a subject treatment schedule is developed and correctly implemented. Making sure that adequate personnel, space, and supplies available at least a week prior to anticipated patient arrival.
• Oversee and assure that subjects are recruited and properly assigned to studies.
• Assure that informed consent is properly obtained.
• Double check and assure that data are properly recorded and correctly placed in the regulatory binders.
• Overseeing subject visits and blood collections are smooth and uneventful. Assuring that specimens are properly processed and shipped. Ensuring medication dispensing/supplies/incentives is carried out and documented appropriately
• Complete investigational product accountability documentation, and ensure product accountability is accurate if indicated.
• Develop source documents for assigned studies, manage data collection, ensure all AEs are identified and reported appropriately.
• Enter required data on paper, spreadsheets or electronic CRFs, audit records for accuracy, resolve discrepancies, and correct as necessary.
• Coordinate visits with external monitors and internal quality assurance to assure compliance with protocol, SOPs, regulations and guidelines.
• Collect, organize and maintain all essential documents required for study regulatory files.
• Ensure research equipment is properly maintained/calibrated
• Serves as liaison between sponsors, investigators, departmental research personnel and other individuals assigned to the study.
Percentage Of Time 50
• Coordination and management of the clinical study, communications with the sponsor, and authorities, visit coordination.
• Plan, direct, or coordinate clinical research project. Direct the activities of workers engaged in clinical research project to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data.
• Direct the activities of research personnel to ensure quality patient care and adherence to research principles and policies.
• Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, university and/or regulatory bodies.
• Help write/edit/prepare data for manuscripts
Train other research staff/students in research related activities.
Percentage Of Time 30
• May plan budgets, ensures adherence to policies and procedures. Ensure services area in compliance with professional standards, state and federal regulatory requirements.
• Collaborates with the PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.
• Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer
• Assists the study/project PI in study feasibility assessments as requested.
• Monitors the research staff in effective use of laboratory and safety measures.
• Coordinate inventory, order processing and distribution of products and services.
Other duties as assigned: The University has the right to add or change certain duties at any time.
Percentage Of Time 20
Do the essential functions of this job require lifting? Yes
The physical demands described here are representative of those that must be met by any employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to walk, sit and use hands. The employee is regularly required to reach with hands and arms and is occasionally required to stand. The employee must occasionally lift and/or move up to 20 pounds. There are no special vision requirements for this job.
Describe Work Environment
Duties are routinely performed in a typical laboratory setting. While performing duties in this setting the employee may be exposed to fumes or airborne particles, toxic or caustic chemicals, extreme cold (non-weather), and risk of electric shock.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be available to enable individuals with disabilities to perform the essential functions.
• Curriculum Vitae
• Letter of Recommendation #1
• Letter of Recommendation #2
• Letter of Recommendation #3
• Cover Letter
To apply visit: http://apptrkr.com/1176824