Clinical Research Coordinator

Retina Consultants San Diego; Poway (CA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Year-end bonus

Paid vacation days

Medical, Dental, Vision insurance

Job summary

Retina Consultants San Diego (RCSD) in Poway is seeking a Clinical Research Coordinator to review protocols, collect essential regulatory documents, and manage all site-level trial activities.

You will collaborate with investigators, coordinators, sponsors and staff to recruit subjects, obtain informed consent, perform study procedures, enter data into the EDC system, and ensure compliance with ICH-GCP and privacy requirements.

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 with proficiency in Excel, Word, and Outlook.
• Strong written and verbal communication skills for professional documentation and interaction.
• Effective interpersonal skills to work with diverse teams in research and clinic departments.

Responsibilities

• Review and understand research protocols.
• Collect startup essential Regulatory documents.
• Manage regulatory documents and license/IB/SAE processes.
• Coordinate with PI, Sub-I, CRCs, RAs, MAs, and sponsors to conduct trials.
• Manage 10-20 patients per study following protocol and schedule.
• Assist with subject recruitment and screening per inclusion/exclusion criteria.
• Conduct study procedures, including consent, blood draws, and data collection.
• Enter data into EDC and resolve sponsor queries.
• Ensure privacy and confidentiality per ICH-GCP and regulations.

Skills

Communication skills

Interpersonal skills

MS Office proficiency

Documentation skills

Education

Certified Phlebotomy Technician (CPT)

Certified Ophthalmic Assistant (COA)

Certified Clinical Research Coordinator (CCRC)

Tools

Excel

Word

Outlook

Job description

About Retina Consultants San Diego (RCSD)

Doctors throughout the world refer their patients to Retina Consultants San Diego, and we are honored to have hundreds of physicians and their family members as patients. For the last 41 years, Retina Consultants San Diego has been known for leading-edge innovative surgery and clinical research. We offer our patients access to the latest innovations in retinal care and technology. All the doctors at RCSD are board-certified retina specialists who have graduated from the nation’s 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, the American Society of Retina Specialists. They are advisors and consultants for dozens of biotechnology, pharmaceutical, and surgical device companies. The team of doctors, photographers, clinical trial coordinators, and technicians are all certified for clinical trials, with rigorous ethical and professional standards. Our research focuses on blinding diseases such as age-related macular degeneration, retinal venous occlusive diseases and diabetic retinopathy.

Click Here to Learn More About Our Enrolling Studies

The Clinical Research Coordinator 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

CRC Duties

• Responsible for reviewing and comprehending research protocols.
• Responsible for collecting start-up essential Regulatory documents
• 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)
• Collaborates with Principle 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.
• Manages and is 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, 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.
• Adheres to compliance of privacy and confidentiality requirements and standards. Adheres to ICH-GCP, OSHA, and ALCOA-CCE and compliance regulations for clinical trials.
• Assists with and oversees quality assurance of study activities; ensures quality data.
• May interface with Institutional Review Board (IRB) and Protocol amendments, continuing reviews, Serious Adverse Event (SAE) reporting, and Sponsor correspondence.
• May contribute to portions of study presentations, and SIV meetings and travel.
• Ability to assist other Coordinators with coverage of coordinating patients, prepping charts, monitoring visits, Regulatory duties, other.
• Assist with billing and invoicing for all study related financial purposes.
• Other study related tasks are subject to be required as the demands change.

General 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

• 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.

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

Work Setting

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

Feel free to visit our website at www.rcsd.com.