Research Regulatory Assistant

3 weeks ago

Houston, United States Retina Consultants of Texas Full time

Overview:
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
- Certification Opportunities

Retina Consultants of Texas (RCTX) is one of the largest and most respected retina-only ophthalmology practices in the United States, committed to Preserving the Patient's Vision. RCTX has three certified research centers and is home to the Greater Houston Retina Research Center, one of the country’s leading sites for retinal research. 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 an ocular oncology division, which focuses on cancer treatments for the eye. Our surgeons have studied at some of the most renowned institutions in the nation and all have graduated at the very top of their classes.

Retina Consultants of Texas (RCTX) is part of Retina Consultants of America (RCA), the largest network of leading retina specialists with the mission of saving sight and improving patient lives through innovation and the highest quality care. Through RCA's physician-centered practice management model, physicians continue to drive clinical and practice culture while benefiting from the available business expertise, resources and shared best practices.

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

Retina Consultants of Texas 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**:
**Duties and Responsibilities**:

- Compiles and prepares materials for submission to regulatory agencies
- Reviews clinical protocols to ensure collection of data needed for regulatory submissions
- Identifies relevant guidance documents
- Occasional travel to other Retina Consultants of America Research clinics for regulatory support
- Assists in communicating study requirements to all individuals involved in the study
- Assists with creation and distribution study documentation to the internal RCTX Research study team in accordance with sponsor requirements and RCTX Research policies and procedures including, but not limited to, study protocols, financial disclosure forms, FDA 1572 forms, study site logs and other essential documents.
- Assists with completion of study documentation of study files to the Sponsor and/or CRO in accordance with sponsor requirements and RCTX Research policies and procedures including, but not limited to, study protocols, financial disclosure forms, FDA 1572 forms, study site logs and other essential documents.
- Assists with maintaining electronic files in Clinical Trial Management System (RealTime) and any other sponsor portals where electronic files may be kept (i.e., Medpace, PPD, Activate/GoBalto, VeevaVault, DrugDev, CLIX, etc.).
- Continuously updates the internal study progress tracker.
- Assists with maintaining effective and ongoing communication with sponsor, research team, Directors, and PI during the course of the study.
- Assists with ensuring protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations.
- Other duties as assigned

Qualifications:
**Skills/Competencies**:

- Knowledge regarding GCP, FDA
- Knowledge of medical terminology and clinical research
- 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 2+ years’ experience in Research in lieu of degree

**Experience Requirements**:

- Applicant must have “hands-on” research experience and working knowledge of FDA regulations, OHRP regulations, ICH and GCP guidelines, and document review.

**Physical Demands**:

- Must be able to sit for long periods of time
- Must be able to write
- Must be able to read medical charts

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