Clinical Research Coordinator
- Pasadena, CA
- $30.00-35.00 per hour
- Permanent
- Full-time
- Administratively and clinically manage an average of six to eight clinical trials
- Adhere to Research SOPs
- Adhere to Good Clinical Practices and the Study Protocols
- Discuss the Study Protocols with patients and verify the informed consent information
- Provide patient with written communication of their participation (i.e copy of the signed informed consent)
- Meet with the patient for each visit and maintain accessibility to discuss questions/concerns regarding the study
- Complete screening visits according to protocol and taking a detailed and accurate medical history
- Prior to any patient screening, gather as much information and medical history prior to the visit to ensure there are no obvious issues or exclusions
- Dispense study medication in a professional and accountable manner following protocol requirements
- Collect, process and ship blood/urine specimens in the event a Research Assistant is not available
- Perform ECGs and obtain vital signs in the event a Research Assistant is not available
- Schedule all patient research visits and procedures consistent with protocol requirements
- Complete and maintain case report forms per FDF guidelines and review them against the patient’s medical record for completeness and accuracy
- Administer questionnaires/diaries per protocol
- Ensure that non -serious and serious adverse events are properly documented and reported
- Screen all laboratory results when received and follow procedure regarding abnormal results
- Ensure all laboratory results are given to the PI for review of clinical significance
- Ensure the delegation logs and training logs are current and train all appropriate staff on new amendments
- Must be able to review and comprehend the protocol
- Reviews and develops a familiarity with the protocol e.g. study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Attends investigator meetings as required and approved by PI and Lead Study Coordinator
- Possess the ability to create study specific source documentation
- Thorough understanding of FDA, ICH and GCP guidelines.
- Experience with Phase I-IV clinical trials
- Proficiency with computer programs including Microsoft Office Suite
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Must exhibit accurate, complete, legible and timely use of communication methods both handwritten and verbal
- Medical Skills: Comfort with Medical terminology and EKGs, BCLS training required
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)