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Clinical Research Coordinator
Summary of Duties:
Under the direction of the Clinical Research Manager, to ensure and assist with efficient operations of the Clinical Research Department including but not limited to: subject recruitment, subject visit preparation, subject visit scheduling, informed consenting, subject visit workup and diagnostic testing, regulatory and subject binder maintenance and preparation, investigational drug, device and stipend accountability, adherence to study protocols, regulatory requirements and Good Clinical Practice, correspondence with sponsors and Institutional Review Boards.
Under the direction of the Clinical Research Manager, to ensure and assist with efficient operations of the Clinical Research Department including but not limited to: subject recruitment, subject visit preparation, subject visit scheduling, informed consenting, subject visit workup and diagnostic testing, regulatory and subject binder maintenance and preparation, investigational drug, device and stipend accountability, adherence to study protocols, regulatory requirements and Good Clinical Practice, correspondence with sponsors and Institutional Review Boards.
Primary Duties: (* = essential functions)
- To adhere to Occupational Safety and Health Administration (OSHA) and Good Clinical Practice (GCP) guidelines and policies. *
- To promote safety and confidentiality of clinical research participants at all times. *
- To adhere to clinical trial protocols, operating policies and procedures. *
- To perform subject visit preparation including source document and case report form preparation, scheduling study visits per protocol, reminders to subjects of their study visits, ensuring study documents are complete, current and filed correctly. *
- To perform subject recruitment and enrollment by identification of potential subjects per eligibility requirements, contacting, scheduling and screening potential subjects, subject compliance and retention. *
- To perform subject data maintenance, accountability and essential functions of subject binders, regulatory binders, subject stipends, data entry into electronic data capture systems (EDC), tracking systems and data query resolution. *
- To perform designated protocol functions per study protocols such as dosing instruction, informed consent, subject visit workup (including Refractometry, Pachymetry, EDTRS Visual Acuity, Snellen Visual Acuity, diagnostic testing) and instrument calibration & maintenance. *
- To maintain study accountability logs, temperature logs and other essential documents. *
- To maintain investigational drug and device monitoring, shipments and accountability. *
- To interact and communicate (both verbally and written) effectively and professionally with Clinical Research Manager, Investigators, Administration, all staff, sponsors, monitors and study participants. *
- To correspondence between sponsors, monitors, Institutional Review Boards (IRB) and site. *
- To provide accurate, complete and timely documentation in accordance with study protocols and Good Clinical Practice guidelines. *
- Additional duties as assigned
Position Requirements:
- High School Diploma or GED, some college preferred
- 1-2 years ophthalmic experience, Certified Ophthalmic Assistant certification preferred
- 1-2 years clinical research experience
- Requires general knowledge of ophthalmology and medical terminology
- Requires completion of Good Clinical Practice training, or working toward such training
- Requires strong computer competency including intermediate knowledge and experience with Excel, Microsoft Office software, data management programs and the ability to easily adapt to new software applications or data management systems.
- Requires ability to maintain strict confidentiality of all subjects and clinical research protocols.
- Requires ability to work well in a team situation.
- Requires ability to adapt to additional assigned roles or alternate site location.
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