Research Assistant/Refractionist
Retina Consultants San Diego (RCSD) is a leading retinal care provider known for innovative surgery and clinical research. For over 41 years, RCSD has offered patients access to the latest advancements in retinal care. Our board-certified retina specialists, who have graduated from top ophthalmology programs, are active members and lecturers in professional societies and serve as advisors to biotechnology, pharmaceutical, and surgical device companies. Our team is certified for clinical trials with a focus on blinding diseases such as age-related macular degeneration, retinal venous occlusive diseases, and diabetic retinopathy.
About the role
This position reports to the Clinical Research Manager. The primary responsibility is performing Visual Acuity Examinations per protocol and maintaining certifications for both licensure and the BCVA lanes.
Responsibilities
- Review and comprehend research protocols.
- Collect start-up essential regulatory documents, including:
- Signed and filled out 1572 (original and updates)
- CVs for all investigators (original and updates)
- Medical licenses for all investigators (original and updates)
- Financial Disclosure forms from all participating investigators (original and updates)
- GCP certificates for all participating investigators (original and updates)
- Signed and dated protocol signature page (original and updates)
- Signed and dated Investigator Brochure (IB) (original and updates)
- Collaborate with Principal Investigator (PI), Sub-Investigator (Sub-I), Clinical Research Coordinators (CRCs), Research Assistants (RAs), Medical Assistants (MAs), Ophthalmic Techs, Sponsors, etc., to conduct and focus on an indication for a specific trial.
- Assist in recruiting potential subjects and phone screenings.
- Schedule patients within inclusion and exclusion criteria.
- Conduct study-related procedures, including medical history collection and adverse events patient visits by following protocol and schedule of events for each visit.
- Manage study-related inventory.
- Handle data collection and data management, inputting into appropriate Electronic Data Capture (EDC) and resolving queries in Sponsor database.
- Work with Sponsors and Clinical Research Associates (CRA) monitors for conducting and collecting appropriate research data.
- Adhere to compliance of privacy and confidentiality requirements and standards, ICH-GCP, OSHA, and ALCOA-CCE regulations for clinical trials.
- Assist with and oversee quality assurance of study activities; ensure quality data.
- Interface with Institutional Review Board (IRB) for protocol amendments, continuing reviews, Serious Adverse Event (SAE) reporting, and Sponsor correspondence.
- Contribute to portions of study presentations, Site Initiation Visit (SIV) meetings, and travel.
- Assist other Coordinators with coverage of coordinating patients, prepping charts, monitoring visits, regulatory duties, etc.
- Assist with billing and invoicing for all study-related financial purposes.
- Perform other study-related tasks as required.
Qualifications
- Excellent computer skills and ability to learn new computer programs.
- Proficient knowledge of Excel, Word, and Outlook.
- Strong written and verbal communication skills for professional interaction and effective documentation of research procedures.
- Ability to read, comprehend, and discuss research materials.
- Effective interpersonal skills and ability to work with a variety of personnel within research and clinic departments.
- Courteous, respectful of co-workers, and maintain a safe and collegiate workplace environment.
Preferred Skills
- Knowledge of or experience in Ophthalmology.
- Certified Ophthalmic Assistant (COA) Certification.
- Medical Assistant (MA) certification and experience with patient care.
Benefits
- Year-end bonus
- Paid vacation days
- Employer-sponsored Medical, Dental, Vision, Life Insurance benefits
- 401K and 401K Roth match contributions
Schedule
This is a full-time position with 8-hour shifts, Monday through Friday.
Work Setting
Poway Location