Location
San Antonio, TX | United States
Job description
SCOPE: Under minimal supervision, is responsible for the collection, coordination, processing and quality control of clinical trial data. May assist with screening patients for research protocols. Maintains research protocol information, regulatory documents and other research files as applicable. Works in compliance with Urology San Antonio Research Department (USARD) Standard Operating Procedure (SOP), principles of Good Clinical Practice and all applicable federal, state, and local regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Extrapolates data, completes case report forms, and ensures timely data submission in accordance with USARD SOP.
- Actively prepares for and participates in monitoring and auditing activities. Assists in ensuring that all queries are resolved in a timely manner in accordance with USARD SOP and sponsor requirements.
- Responsible for processing, filing and maintaining protocol regulatory documents.
- May assist with screening patients for potential study enrollment.
- Responsible for assisting with patient scheduling for procedures required to maintain protocol compliance.
- Responsible for assisting with coordinating patient follow-up visits and timely data submission.
- Responsible for assisting with collection and processing of specimens, imaging documents, or other items required for research purposes.
- Responsible for ordering and maintaining research supplies.
- Responsible for assisting in the investigational drug accountability process.
- Maintains research records in a confidential manner according to practice policies, sponsor confidentiality agreements, HIPAA guidelines and any other applicable regulations.
- May lead and mentor other data coordinators at the site/location
- May be responsible for coordinating patient billing and research payout/payment tracking.
MINIMUM QUALIFICATIONS: High school diploma or equivalent required, some college coursework or other relevant background preferred. Three-five years of medical office experience (preferably in oncology or urology) and knowledge of medical terminology required. Minimum three years of experience as data coordinator required. SoCRA or ACRP certification preferred.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision correctable to 20/20. Requires occasional lifting of up to 30 pounds.
Job tags
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