Responsibilities:
- Complete initial regulatory document submissions as required by Sponsor
- Oversee the training and certification of all study staff
- Create study source documents
- Implement pre-screening process for potential candidates, if possible
- Perform study procedures in accordance with ICH-GCP regulations and study protocols, which can include, but is not limited to:
- Consenting patients
- Medication and adverse event review
- Refraction
- Lab collection, processing, and shipping – previous IATA training is a plus
- Analyze clinic flow in order to strategically use clinic workup rooms, properly make use of physician’s time/schedule, and minimize patient’s appointment time
- Oversee research patient visit schedule and modify doctors/tech/staff’s schedule to comply with visit window requirements
- Work collaboratively with the investigators, study vendors, Sponsors, and study monitors to ensure that trial is properly conducted, all data is correct and complete, and study timelines are met
- Discuss and inform study participants with PI to ensure patient safety and PI oversight
- Report adverse events/serious adverse events to Sponsor, following Sponsor required deadlines, and follow up as necessary
- Assess and maintain quality control of subject paper source, electronic subject data, and regulatory documents
- Cultivate enthusiastic and professional relationships with patients and sponsors alike
Requirements:
- Medical experience preferred, but not needed
- Analytical mindset.
- Attention to detail.
- Exceptional interpersonal skills.
- Outstanding written and verbal communication.
- Excellent organizational skill.
- Willingness to continually self-educate.
Job Type: Full-time
Pay: $25.00 - $32.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person