Clinical Research Coordinator

About the Company

Doctors throughout the world refer their patients to Retina Consultants San Diego (RCSD). For the last 41 years, RCSD has been known for leading-edge innovative surgery and clinical research, offering patients access to the latest innovations in retinal care and technology. All doctors at RCSD are board-certified retina specialists who have graduated from top ophthalmology programs, including the Wills Eye Institute, Stanford University, and the Johns Hopkins Wilmer Eye Institute. They are active members and lecturers at the American Academy of Ophthalmology, the Retina Society, and the American Society of Retina Specialists, and serve as advisors and consultants for biotechnology, pharmaceutical, and surgical device companies.

The team of doctors, photographers, clinical trial coordinators, and technicians are all certified for clinical trials, adhering to rigorous ethical and professional standards. Research focuses on blinding diseases such as age-related macular degeneration, retinal venous occlusive diseases, and diabetic retinopathy.

About the Role

The Clinical Research Coordinator (CRC) is responsible for reviewing and understanding research protocols, collecting essential regulatory documents, and managing all aspects of clinical trials at the site level. CRCs collaborate closely with investigators, research assistants, and sponsors to ensure the smooth execution of each trial.

Reports to: Clinical Research Manager

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.
• Manage and serve as the Primary Coordinator for approximately 10-20 patients for clinical trial studies by following each research study protocol.
• Assist in recruiting potential subjects and phone screenings; schedule patients within inclusion and exclusion criteria.
• Conduct study-related procedures, including consenting, blood draws, specimen shipment, EKGs, medical history collection, and adverse events patient visits by following protocol and schedule of events for each visit.
• Responsible for study-related inventory.
• Responsible for data collection and data management, inputting into appropriate Electronic Data Capture (EDC), and resolving queries in Sponsor database.
• Assigned to clinical trials and 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; adhere to ICH-GCP, OSHA, and ALCOA-CCE and compliance regulations for clinical trials.
• Assist with and oversee quality assurance of study activities; ensure quality data.
• May interface with Institutional Review Board (IRB) for protocol amendments, continuing reviews, Serious Adverse Event (SAE) reporting, and Sponsor correspondence.
• May contribute to portions of study presentations, SIV meetings, and travel.
• Ability to 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

• 1-3 years of Clinical Research experience as a Research Assistant, Clinical Research Coordinator, or Pre-Clinical Researcher required.
• Certified Phlebotomy Technician (CPT) to assist with blood draws and specimen processing as needed.
• Excellent computer skills and ability to learn new computer programs; proficient knowledge of Excel, Word, Outlook.
• Strong written and verbal communication skills needed to interact professionally and effectively in the work environment, as well as to effectively document research procedures.
• Ability to read, comprehend, and discuss research materials.
• Effective interpersonal skills; ability to work with a variety of personnel within the research and clinic departments.
• Courteous, respectful of co-workers, and maintain a safe and collegiate workplace environment.

Preferred Qualifications

• Knowledge of or experience in Ophthalmology.
• Certified Ophthalmic Assistant (COA) Certification.
• Medical Assistant (MA) certification and experience with patient care.
• Laboratory essential duties (collect and process specimens).
• Certified Clinical Research Coordinator (CCRC) certification.

Benefits

• Competitive salary – based on experience
• Year-end bonus
• Paid vacation days
• Employer-sponsored Medical, Dental, Vision, Life Insurance benefits
• 401K, 401K Roth match contributions

Schedule

This is a full-time position; 8-hour shifts, Monday through Friday.

Work Setting

Poway Location