Clinical Research Coordinator - Ophthalmology - No Weekends, Full Benefits!

EyeCare Partners - Lexington, KY

Full-time - Entry Level

Lexington, KY

1,001-5,000 employees

Ambulatory Health Care Services

About the position

The Clinical Research Coordinator at EyeCare Partners plays a vital role in the coordination of research protocols within the ophthalmology field. Under the guidance of the Research Manager, this position is responsible for various aspects of clinical trials, including subject recruitment, enrollment, and the implementation and follow-up of research protocols. The Clinical Research Coordinator is expected to uphold good clinical practices by being well-versed in federal regulations and guidance documents that govern clinical trials and the protection of human subjects. This role is essential in ensuring that clinical investigations are conducted ethically and efficiently, contributing to the advancement of eye care and improving patient outcomes. In this position, the Clinical Research Coordinator will engage in subject screening, recruitment, and enrollment processes, as well as follow-up procedures. They will be responsible for pre-study preparations and problem-solving throughout the clinical trial process. A thorough understanding of the research protocol is crucial, as the coordinator will collect, process, and ship research specimens, including performing blood draws, while adhering to appropriate training protocols. Documentation is a key component of this role, requiring the maintenance of study-related procedures and events on case report forms (CRFs) or through electronic data capture (EDC). The coordinator will also participate in monitoring visits, review CRFs with sponsors, and handle data queries, ensuring that all regulatory documents such as Human Investigation Committee (HIC) applications, Informed Consents, and Adverse Event (AE) Reports are prepared accurately. Effective communication is paramount in this role, as the Clinical Research Coordinator will interact with subjects, the research team, principal investigators, ancillary staff, study sponsors, and primary care providers. They will be responsible for consenting and conducting study visits for various types of trials, monitoring for adverse events, and ensuring accountability for study devices and articles. Additionally, the coordinator will assist in budget preparation and collaborate with the regulatory division to implement study protocols while maintaining subject confidentiality. The ability to complete tasks by deadlines, investigate solutions to problems, and work effectively in a team environment is essential for success in this position. The Clinical Research Coordinator may also be required to assist in other departments as needed.

Responsibilities

• Participate in subject screening, recruitment, enrollment and follow-up procedures, pre-study preparation, problem solving and maintenance of clinical trials.
• Read and have full understanding of research protocol.
• Collect, process, and ship research specimens, including blood draws, following appropriate training.
• Document and maintain all study related procedures and events on case report forms (CRFs) or electronic data capture (EDC), participate in monitoring visits, review CRFs with the sponsor, handle data queries.
• Prepare complex regulatory documents such as Human Investigation Committee (HIC) applications, Informed Consents, complex amendments, Progress Reports, Adverse Event (AE) Reports and Protocol Deviations.
• Communicate effectively with subjects, research team, principal Investigators, ancillary staff, study sponsors and primary care providers.
• Consent and conduct study visits for device trials, data collection/no risk trials, and study article/some risk trials as appropriate to education, training and work experience.
• Monitor for AEs, distribute device/study article and monitor device/study articles accountability as appropriate.
• Prepare for and participate in audits by sponsors and external regulators.
• Utilize effective communication skills in patient/family interaction, incorporating specific age, cultural or developmental needs.
• Assist in budget preparation; plan and implement study protocols with regulatory division.
• Protect subject confidentiality.
• Complete tasks and projects by deadlines set by supervisor.
• Investigate solutions to problems and determine best course of action.
• Work effectively in a team environment.
• Perform all other duties as assigned, which may include assisting in other departments.

Requirements

• Minimum 2 years of clinical research experience preferred.
• Excellent interpersonal and professional skills to work effectively with others and provide superior customer service to patients/subjects and their families.
• Ability to handle confidential matters; adheres to all HIPAA guidelines/regulations.
• Understands medical terminology, procedure codes and diagnosis codes as it applies to recruiting subjects for Research.
• Communicates clearly and professionally, both orally and in writing with patients, team members, physicians, payers, and office coordinators.
• Knowledge of spelling, punctuation, grammar, sentence structure, and proper English usage.
• Ability to multi-task duties, prioritize workload, organize files and workspace, and be self-directed in an open office setting.
• Strong proficiency in MS Office Suite, including Word and Excel, Outlook or other email system, use of computerized medical tracking systems, use of insurance websites, internet search capabilities and other applications as appropriate.
• Strong analytical and problem-solving skills.

Benefits

• Full benefits package including health insurance, dental insurance, and vision insurance.
• 401k retirement plan with company matching contributions.
• Paid time off and holidays.
• Flexible scheduling options.