About this role
Purpose: To act as the assistant to the Clinical Trials Manager and Lead by helping with day-to-day trial activities to ensure compliance with regulatory agencies. Duties include reviewing protocols, scheduling, and screening patients, and performing necessary exams/testing in relation to the study.
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Job Duties and Responsibilities:
- Reviews and understands trial protocols and requirements in order understand the inclusion/exclusion criteria and be able to explain all the details of the study to candidates and to execute the informed consent
- Assists in the recruitment and screening of potential trial candidates by reviewing patient charts and responding to referred patients through recruiting services
- Assists in scheduling participants for visits and procedures to ensure study protocol is followed during the visit
- Performs or assists with any necessary preliminary eye exams and testing on potential candidates to determine qualification for a trial
- Assists with processing blood samples, urine samples, and/or pregnancy tests
- Processes any trial related specimens and maintains the appropriate documentation
- Verifies Electronic Medical Records (EMR) and paper charts are accurate and that exam/tests results are being consistently documented in any applicable records
- Assists in completely weekly enrollment/screening logs
- Responds to system or sponsor generated queries regarding participants
- Maintains monthly equipment maintenance logs for scales, tonometer, centrifuges, thermometers, and other equipment used during a study
- Maintains daily temperature logs for any onsite investigational products
- Submits requests for patient compensation checks
- Acts as back-up to the Clinical Trials Manager/Lead to answer any patient, sponsor, or physician questions regarding current studies
- Participates in trial specific training courses to obtain any required certifications, including but not limited to IATA Certification and Good Clinical Practices Certification
- Maintains strict patient protocols in accordance with practice policies/ HIPAA requirements
- Performs all duties to SoCal Eye’s Service Standards of Excellence and Teamwork
- Performs other duties as assigned
Qualifications
Requirements:
- Education: BA/BS degree preferred
- Experience: 1-2 years ophthalmology, optometry, and/or related clinical research required
- License/certification: MA, COA, COT, or OSC preferred, but not required
- Limited phlebotomy technician (LPT) required, ability to process and handling blood
- Outstanding commination skills, strong interpersonal skills, and ability to communicate in English; Bilingual in Spanish, a plus
- Excellent customer service skills with ability to relate to patients of diverse backgrounds
- Intermediate Computer skills; MS office, Power Point, Excel, required
Specifications:
- Working Hours; M- F; 8:30 AM – 5:00 PM
- Work is performed in a clinical setting. Must be able to stand, walk, or sit for up to 8 hours with bending, stooping, squatting, sitting, twisting, and reaching. Including ability to frequently reach with hands and arms, and repeat the same movements. Occasional lifting of up to 15lbs.
- Position: Clinical Trials Assistant
DOL Status: Non-Exempt/ Full-Time
Pay Range: $19 - $27
Reports to: Clinical Trials Manager
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It is the policy of SoCal Eye to ensure equal employment opportunity without discrimination or harassment since race (including hairstyle/texture), color, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, citizenship, national origin, genetic information, or any other characteristic protected by law. SoCal Eye prohibits any such discrimination or harassment.
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