Description
Support the Clinical Research department with assistance with subject recruitment and other departmental functions utilizing the Good Clinical Practice (GCP).
Professional Duties
- Complete case report forms and electronic data capture and submit to sponsor.
- Demonstrate understanding and competency of the Informed Consent process and respond to all clinical and procedural questions.
- Ensure that all study tests, visits, and evaluations are performed per protocol.
- Assess lab data and clinical signs for potential adverse reactions. Report adverse events or serious events to sponsor.
- Promote subject compliance by providing support and education. Provide information for treatments and reactions.
- Prepare laboratory shipments per International Air Transport Association (IATA) guidelines.
- Maintain adequate inventory of supplies for exam rooms and laboratory. Dispose of expired.
- Monitor all daily temperature logs per protocols and notify Manager immediately when temperature logs are out of parameters.
- Follow all International Conference on Harmonization (ICH) Good Clinical Practices and pertinent regulatory guidelines in addition to company policies and procedures.
- Complete and maintain all patient screening logs, study tracking documents and other paperwork timely and accurately.
- Visit Research Associate Program (RAP) members and staff to disseminate information on studies.
- Review charts and database searches for potential patients and contact potential subjects who have been approved for contact.
- Comply with Federal Drug Administration (FDA) regulations for conducting clinical trials.
- Assist with EKGs and other study procedures as requested.
- Perform other duties as assigned.
- Serve as an ambassador for Desert Oasis Healthcare and Family Hospice Care at all times and positively shape the customer experience
- Be accountable for your work
- Speak clearly and use understandable language (avoid medical jargon or slang)
Qualifications
- High School Diploma or equivalent required.
- 1 to 2 years experience in a health care environment.
- Basic computer skills. Knowledge of Word and Excel a plus. Must type minimum of 40 wpms.
- Ability to manage time and stay organized.
- Completion of IATA training within 30 days of hire.
- Completion of GCP Training within 30 days of hire.
- BLS required within 60 days of hire.
- Good communication skills, detail oriented, critical thinking and problem solving skills. Excellent customer service and telephone etiquette skills. Bilingual a plus.
Physical Demands
Type Description
Sitting
Approximately 25% of day
Standing
Approximately 75% of day
Walking
Approximately 25% of day
Lifting
0 - 30 lbs (charts, supplies) - approximately 10% of day
Bending
Approximately 15% of day
Hearing/Visual Acuity
Adequate for use with computers, telephone and or Blackberry - Approx 50% of day
Computer
Highly technical work environment - Must be able to work = 2 hours / day using keyboard, mouse and monitor
Reaching
Above head 75 degrees - approximately 10%.
Hand grip dexterity
Not Applicable