Clinical Research Coordinator

1 week ago

Lexington, Kentucky, United States Retina Associates of Kentucky Full time
Job Title: Clinical Research Coordinator

EyeCare Partners is the nation's leading provider of clinically integrated eye care. Our national network of over 300 ophthalmologists and 700 optometrists provides a lifetime of care to our patients with a mission to enhance vision, advance eye care and improve lives.

Based in St. Louis, Missouri, over 650 ECP-affiliated practice locations provide care in 18 states and 80 markets, providing services that span the eye care continuum.

For more information, visit www.eyecarepartners.com.

Job Summary

Under the direction of the Research Manager, the Clinical Research Coordinator is responsible for the coordination of research protocols, including subject recruitment, enrollment, and implementation and follow up of protocols.

The Clinical Research Coordinator promotes good clinical practice in the conduct of clinical investigations by possessing knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject's protection.

Key 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.
  • Patient/family interaction - utilize effective communication skills; incorporate 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 determines best course of action.
  • Work effectively in a team environment.
  • Perform all other duties as assigned, which may include assisting in other departments.
Requirements/Qualifications
  • 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
Relationships

Reports to: Research Manager

Directly Supervises: Not applicable

Work Schedule: Varies, but typically Monday through Friday. Potential for Saturday work hours depending on workload.

FLSA Status: Non-exempt

Working Conditions: Minimal physical activity (standing, bending, sitting, walking, pulling and lifting) for most of the work shift. Clean office environment. Possible hazardous chemicals.

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