Research Coordinator
5 days ago
Position Summary: The Clinical Research Coordinator will manage and execute clinical trials focused on retinal diseases, including geographic atrophy, macular degeneration, and diabetic retinopathy. The role involves direct patient interaction, sample collection and processing, regulatory compliance, and collaboration with investigators and sponsors to ensure the successful completion of research studies.
Qualifications/Skills:
- High school diploma or GED required
- Minimum of 1-2 years of clinical research experience, preferably in ophthalmology or retinal diseases.
- Familiarity with clinical trial software and electronic data capture (EDC) systems.
- Certifications: Certified Clinical Research Coordinator (CCRC) or equivalent preferred.
- Strong organizational and multitasking abilities.
- Excellent communication and interpersonal skills. Attention to detail and proficiency in medical terminology.
- Bilingual (English/Spanish) candidates strongly preferred
Responsibilities/Duties:
1.Study Coordination:
- Manage all aspects of assigned clinical trials, including patient scheduling, visit coordination, and protocol adherence.
- Support study start-up activities, including site initiation, regulatory submissions, and training.
Track and report study progress, patient enrollment, and retention to investigators and sponsors.
Patient Care and Procedure Execution:
Screen, recruit, and consent eligible participants according to study protocols.
- Conduct study-specific procedures, including:
- Drawing, processing, and shipping blood samples and other lab specimens.
- Performing and recording high-quality electrocardiograms (ECGs).
Administering questionnaires, vision tests, and other assessments
Regulatory and Documentation Compliance: Maintain accurate and complete source documentation, regulatory binders, and case report forms (CRFs).
Submit protocol amendments, safety reports, and continuing reviews to IRBs.
Ensure compliance with Good Clinical Practice (GCP), FDA, and institutional guidelines.
Data Management
Accurately collect and enter study data into electronic data capture (EDC) systems.
- Monitor data quality and resolve discrepancies with sponsors or CROs.
Maintain strict confidentiality of patient and study information.
Communication and Team Collaboration:
Serve as the primary point of contact for sponsors, CROs, and monitors.
Collaborate with investigators, clinicians, and site staff to address protocol requirements.
Communicate study updates and findings to the research team.
Training and Development
Provide training to staff and new team members on study protocols and procedures.
- Stay current with advancements in retinal research and clinical trial methodologies.
Additional Requirements:
- Willingness to stay updated on study requirements.
- Ability to follow detailed protocols.
- Adherence to data privacy and security regulations in research settings.
- Some overtime may be required
Work Environment:
Standard work hours with occasional flexibility to support patient and study schedules, including some evenings or weekends as needed.
Essential Physical Functions:
- Ability to stand or sit for extended periods during imaging sessions.
- Dexterity and coordination to operate imaging devices and handle delicate equipment.
- Occasional lifting of up to 20 pounds for equipment setup and maintenance.
American with Disabilities Act (ADA) Statement: External and internal applicants, as well as position incumbents who become disable, must be able to perform the essential job specific functions (listed within each job responsibility) either unaided or with the assistance of a reasonable accommodation to be determined by the organization on a case-by-case basis.
Equal Opportunity Employer M/F/D/V and Drug Free Workplace _______________________________________
Job Type: Full-time
Pay: $ $30.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Work Location: In person
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