Clinical Research Coordinator Ophthalmology exp required

Texas Retina Associates; Dallas (TX); On-site; USD 42,000 - 58,000; Full time

Job summary

Texas Retina Associates in Dallas is seeking a Clinical Research Assistant to help identify, evaluate and recruit potential patients for ongoing studies and manage data collection. Located in the Dallas Main Office, the role supports the Clinical Research Department and ensures regulatory compliance and accurate documentation.

The position requires attention to detail, strong communication and the ability to work in a fast-paced environment while upholding HIPAA and FDA guidelines.

Qualifications

• High school diploma or GED required.
• One year of Clinical Research Assistant experience in ophthalmic practice required; retinal experience preferred.
• Training in medical terminology required.
• Experience with NextGen and Patient Management preferred.
• Ability to read, write and communicate effectively in English.

Responsibilities

• Manage data collection, process data queries and ensure resolution.
• Identify adverse events and reports per protocol guidelines.
• Assist in the planning and design of source documents for study protocols as required.
• Update and review regulatory documents to include annual IRB approvals, protocol amendments, and safety reports.
• Responsible for the timely completion of identified study documents including case report forms.
• Responsible for ensuring compliance with FDA and GCP guidelines.
• Conduct pre-study, initiation, monitoring, and close out visits with sponsor representatives.
• Greet patients in a cordial, friendly and prompt manner.
• Escort patients to examining rooms, verify patient information and make necessary documentation to patient charts.
• Present patient history summary and alert Ophthalmologist to changes in visual acuity, elevated extraocular pressure or blood pressure, etc.
• Administer topical ophthalmic or oral medications.
• Counsel patients in the office and on the phone concerning physician's orders, use of drops, drugs, and answer questions.
• Maintain knowledge of operation and maintenance of clinical equipment, drugs, and supplies.
• Obtain all appropriate consent forms.
• Contribute to maintaining a clean and sterile environment.
• Adhere to all OSHA and Infectious Waste Procedures.
• Perform tasks in support of the Clinical Research Department as needed.
• Maintain compliance with all practice procedures and protocols.
• Maintain HIPAA compliance for all patient information.
• Notify appropriate staff in a timely manner regarding adequate supplies.
• Cleaning and Care of Ophthalmic Instruments.

Skills

Analytical skills

Computer skills

Communication

Interpersonal skills

Attention to detail

English proficiency

Education

High school diploma or GED

Medical terminology training

Tools

NextGen

Patient Management system

Job description

Job Purpose

This position will be located in the Dallas Main Office and will report directly to the Clinical Operations Officer. The position will help to identify, evaluate, and recruit potential patients for ongoing studies and is responsible for managing data collection.

Texas Retina Associates is Texas’ largest, most experienced ophthalmology practice focused specifically on the diagnosis, medical and surgical management of diseases of the retina and vitreous. Our fellowshipped and specialty trained physicians care for the most complicated retina conditions such as ocular cancer and uveitis. This physician owned medical group provides services at 14 locations throughout the DFW metroplex, Waco, Wichita Falls and Lubbock.

Essential Duties

• Manage data collection, process data queries and ensure resolution.
• Identify adverse events and reports per protocol guidelines.
• Assist in the planning and design of source documents for study protocols as required.
• Update and review regulatory documents to include annual IRB approvals, protocol amendments, and safety reports.
• Responsible for the timely completion of identified study documents including case report forms.
• Responsible for ensuring compliance with FDA and GCP guidelines.
• Conduct pre-study, initiation, monitoring, and close out visits with sponsor representatives.
• Greet patients in a cordial, friendly and prompt manner.
• Escort patients to examining rooms, verify patient information and make necessary documentation to patient charts.
• Present patient history summary and alert Ophthalmologist to changes in visual acuity, elevated extraocular pressure or blood pressure, etc.
• Administer topical ophthalmic or oral medications.
• Counsel patients in the office and on the phone concerning physician's orders, use of drops, drugs, and answer questions.
• Maintain knowledge of operation and maintenance of clinical equipment, drugs, and supplies.
• Obtain all appropriate consent forms.
• Contribute to maintaining a clean and sterile environment.
• Adhere to all OSHA and Infectious Waste Procedures.
• Perform tasks in support of the Clinical Research Department as needed.
• Maintain compliance with all practice procedures and protocols.
• Maintain HIPAA compliance for all patient information.
• Notify appropriate staff in a timely manner regarding adequate supplies.
• Cleaning and Care of Ophthalmic Instruments.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Minimum Education and Experience

• High school diploma (or GED).
• One year of experience as a Clinical Research Assistant in an Ophthalmic practice required. Retinal practice experience preferred.
• Training in medical terminology required.
• Experience with NextGen and Patient Management preferred.
• Perform triage per specific office protocol procedures.
• Must be able to recognize and appropriately respond to urgent/emergency situations per protocol.
• Ability to read, write and communicate effectively in English, both orally and in writing.
• Excellent interpersonal skills to deal effectively with patients, patient’s family members, physicians, clinicians and administrators.
• Ability to work in a dynamic, fast paced environment.
• Meticulous attention to detail.

Skills and Specifications

• Strong analytical and organizational ability.
• Strong ability to listen, answer all questions as simply as possible and act when needed.
• Excellent computer skills.
• Complete all other duties as assigned.

Physical Requirements

• Sedentary with prolonged sitting and working at computer.
• Prolonged periods of standing, walking and bending.
• Must be able to lift up to 30 lbs. maximum and occasionally lift and/or carry such articles as reports, files and small items.
• Have the hand eye coordination and manual dexterity required to perform all duties.