Why You'll Love this Job
Retina Consultants of Texas (RCTX) is seeking a Research Study Coordinator to join our growing Research team.
The Research Study Coordinator is primarily responsible for coordinating research patient visits according to both the ICH-GCP guidelines and the IRB-approved study protocol and/or manual of procedures.
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
Retina Consultants of Texas 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 is one of the largest and most respected retina-only ophthalmology practices in the United States, committed to Preserving the Patient's Vision. RCT 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, RCT 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 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
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study
- Administer sponsor required questionnaires (i.e. VFQ)
- Works with team member responsible for ordering study supplies (lab kits, shippers, etc.) to ensure adequate inventory is on hand
- Ensures study staff is properly trained on study-related information (i.e. protocol, ICF, manuals, etc.) and that the training is documented
- Creates, manages, and maintains source documents for each trial
- Attends teleconferences and Investigator Meetings as requested by research director
- Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections
- Works with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals
- Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility accurately
- Efficiently completes all study tasks delegated to them (i.e. scribing, VFQ, IOP, etc.)
- Collects updated medical history, adverse events and serious adverse events that need to be reported to the sponsor and IRB within required timeframe
- Conducts and/or participates in the informed consent process/discussion with research participants, including answering any questions related to the study
- Assures that amended consent forms are appropriately implemented and signed
- Acts as a secondary reviewer to provide oversight so that the ICF process is conducted accurately
- Collects data as required by the protocol and enters information into the electronic data capture (EDC) system in the specified timeframe indicated in the study contract.
- Oversees data and ensures that it is being entered correctly and resolves any queries issued within required timeframe
- Collects and reports ALL Adverse Events
- Collects and reports ALL Serious Adverse Events
- Responsible for ensuring all SUSAR/Safety Reports are acknowledged and reviewed
- Coordinates monitor site visits and assists with preparation of site visit documentation
- Works with the monitor to make any corrections needed to meet requirements and deadlines as needed
- Manages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor
Qualifications
Skills/Competencies:
- Efficiently and accurately interviews patients and documents histories
- Demonstrates working knowledge of eye anatomy, disease, symptoms, and ocular medications
- Accurately performs: labs, ECG, tonometry, pupil exam, data entry, and other specified duties
- Possesses excellent organizational skills to independently manage workflow
- Pays meticulous attention to detail
- Takes initiative
- Possesses insight and energy to prioritize quickly
- Demonstrates high-level critical thinking skills
- Cooperates with supervisory staff, physicians, peers, external customers, and patients in a positive, energetic, and professional manner
- Demonstrates excellence in communication skills, both personal and written
- Abounds in organizational and time-management skills
- Demonstrates ability to effectively convey ideas and information
- Able to creatively generate ideas with excellent follow through
Education Requirements
- College degree preferred or significant relevant experience
Experience Requirements:
- Ophthalmic experience preferred
Certifications / Training:
- ICH GCP Training / Certificate
- IATA Certification
Physical Abilities:
- Must be able to stand for long periods of time
- Must be able to write
- Must be able to hold arms at shoulder height
- Must be able to communicate via telephone
- Must have manual dexterity to work with ophthalmic equipment