The Psychiatry and Behavioral Sciences department is seeking a Clinical Research Associate to manage and oversee the day-to-day coordination and operations of assigned clinical research projects, with a focus on recruitment, enrollment, and research activities for FDA-regulated research.
Requirements
- Basic proficiency in Microsoft Office Suite (Word, Excel, Outlook).
- Familiarity with data entry platforms such as REDCap or willingness to learn.
- Good Clinical Practice (GCP) Certification: Demonstrates understanding of GCP guidelines.
- CITI Human Subjects Research Training.
Responsibilities
- Assists in reviewing medical records and conducting preliminary screenings under supervision.
- Supports recruitment efforts for clinical trials, including outreach and communication with potential participants, under the guidance of senior staff.
- Provides logistical support for participant scheduling, visit reminders, and reimbursement processes.
- Coordinates with study teams to ensure protocol-required assessments are completed, with oversight from the Principal Investigator (PI) or senior research staff.
- Supports the preparation and organization of regulatory documents, including IRB submissions and amendments, under supervision.
- Performs data entry and assists with quality control in clinical trial databases (e.g., REDCap, Excel).
- Helps maintain study binders and source documentation in accordance with Good Clinical Practice (GCP) and FDA regulations, under the direction of senior team members.
Other
- Bachelor’s degree in a health-related field, biological sciences, psychology, public health, or a related discipline.
- Some experience in a research or healthcare setting preferred (e.g., through internships, volunteer work, or coursework).
- Strong written and verbal communication skills.
- Ability to interact professionally with participants, clinical staff, and research teams.
- Detail-oriented with strong time management and organizational abilities.
- Ability to follow instructions and adhere to study protocols and regulatory requirements.
- Occasional weekend, overtime, and evening work to meet deadlines
