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POSITION SUMMARY:
Clinical Research Associate is responsible for the collection, coordination, and quality control of clinical trial data. Regulatory coordination of study regulated documents.
ESSENTIAL JOB FUNCTIONS/RESPONSIBILITIES:
1) Takes care of any patient needs promptly and willingly.
2) Extrapolates data, completes case report forms and ensures timely data submission.
3) Utilizes CTMS, local clinical trials database and other resources available to access research forms and keep current all applicable patient reporting and tracking functions.
4) Actively prepares for and participates in monitoring and auditing.
5) Ensures all queries are resolved in a timely manner.
6) Processes, files, and maintains protocol regulatory documents when required in clinic and submission of IRB documents.
7) Assists with coordinating follow up visits and timely data submission.
8) Assists in collection and processing of specimens, imaging documents, or other items required for research purposes.
9) Assists with ordering and maintaining research supplies.
10) Responsible for pulling data for payment in Clinical Trials Management System and updating screening and/or enrollment logs for study protocols.
11) Manages research monitors on site and setting up profiles for research monitors within the EMR.
12) Contacts physician or referring physicians for data follow up and IRB forms for clinic research.
13) Initiates Serious Adverse Event Reporting and follow up.
14) Works in compliance with all applicable research entities and federal, state, and local regulatory bodies.
15) Demonstrates Adult Pediatric Urology & Urogynecology’s mission and core values through actions and words.
16) Other duties as assigned related to the billing practices, policies, and procedures.
17) Must work as a team member and perform actions consistent with established Adult Pediatric Urology & Urogynecology policies and procedures including standards for safety, attendance, punctuality, and personal appearance. Perform other duties as assigned.
Job Type: Full-time
Benefits:
- Dental insurance
- Disability insurance
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- Associate (Required)
Experience:
- Clinical research: 1 year (Preferred)
- EMR systems: 1 year (Preferred)
- Medical office: 1 year (Preferred)
Work Location:
- One location
Work Remotely:
- No
Work Location: One location
