Regulatory Coordinator

Overview

Retina Consultants of Texas (RCTX) is currently looking for a Regulatory Coordinator to join our fast paced growing team! The Regulatory Coordinator is primarily responsible for creation, completion, and maintenance of regulatory study start-up. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience/knowledge and the needs of the organization which are subject to change from time to time.

RCTX offers the following competitive benefits for full-time eligible employees after the introductory period:

• Medical Insurance Plans
• Vision Insurance Plan
• Dental Insurance Plan
• 401K Contribution
• Life Insurance
• PTO and Holiday Pay
• Rewards and Recognition program 

RCTX is one of the largest and most respected retina-only ophthalmology practices in the United States, dedicated to preserving vision for patients throughout the state. RCTX has three certified research centers and is one of the leading sites for retinal research in the country. All Retina Consultants of Texas physicians are board-certified by the American Board of Ophthalmology and specialize exclusively in diseases and surgery of the retina, vitreous and macula. In addition, RCTX has both uveitis and ocular oncology specialty divisions, which focus on inflammation and cancer treatments of the eye. Our surgeons have studied at some of the most renowned institutions in the nation and all have graduated at the top of their classes.

RCTX follows all CDC and local authority protocols to ensure the safety and well-being of the patients, providers, employees and communities. 

RCTX is proud to be an Equal Employment Opportunity and an Affirmative Action Employer. We are committed to creating an inclusive work environment that celebrates diversity

Responsibilities

• Compiles and prepares materials for submission to regulatory agencies
• Reviews clinical protocols to ensure collection of data needed for regulatory submissions
• Participates in internal or external audits
• Identifies relevant guidance documents
• Occasional travel to other RCA Research clinics (locally and/or nationally) for regulatory support.
• Communicates study requirements to all individuals involved in the study.
• Creates and distribute study documentation to the internal RCA Research study team in accordance with sponsor requirements and RCA Research policies and procedures including, but not limited to, study protocols, financial disclosure forms, FDA 1572 forms, study site logs and other essential documents)
• Completes and submits study documentation of study files to the Sponsor and/or CRO in accordance with sponsor requirements and RCA Research policies and procedures including, but not limited to, study protocols, financial disclosure forms, FDA 1572 forms, study site logs and other essential documents
• Maintains electronic files in Clinical Trial Management System (Realtime) and any other sponsor portals where electronic files may be kept (i.e. Medpace, PPD, GoBalto, VeevaVault, etc.)
• Maintains effective and ongoing communication with sponsor, research participants, Director and PI during the course of the study.
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Performs other duties as assigned.

Qualifications

Skills/Competencies:

• Knowledgeable about GCP, FDA regulations
• Knowledge of medical terminology and clinical research industry
• Takes initiative
• Goal-driven mindset
• Strong customer service skills
• Strong analytical and problem-solving skills
• Excellent organizational skills, detail oriented, efficient, and able to multi-task and prioritize effectively
• Excellent interpersonal skills· Strong written and verbal communication skills

Education Requirements

• Bachelor’s Degree and/or 3 years’ experience as a Regulatory Coordinator 

Experience Requirements:

• “Hands-on” regulatory experience and working knowledge of FDA regulations, OHRP regulations, ICH and GCP guidelines, and document review

Physical Abilities:

• Must be able to sit for long periods of time
• Must be able to write
• Must be able to communicate via telephone and email
• Must be able to read medical charts