Maine Eye Center · 3 weeks ago
Clinical Research and Study Coordinator
Portland, ME 04101
Full-time
Onsite
Entry, Mid Level
2+ years expMaine Eye Center is a leading regional ophthalmology practice dedicated to providing high-quality eye care and outcomes. The Clinical Research Coordinator II will assist the Principal Investigator in implementing clinical research studies, manage participant recruitment, and ensure compliance with regulatory requirements.
ConsultingHealth CareHealth DiagnosticsMedical
Responsibilities
Assisting in the recruitment of study participants. Assesses potential study patients and eligibility for inclusion in a particular protocol based on protocol requirements. Reviews all eligibility and ineligibility criteria in the patient’s record. Verifies information with the physician. Interviews patients to gather information for eligibility assessment, explain the study, and obtain signature for the informed consent form
Organizing strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required
Completing follow-up with study participants in prescribed settings as required
Completing record abstraction of source documents, conducting required study measurements, and completing study Case Report Forms in accordance with best practice methods. Conducting a QC check of completed CRFs prior to submission for data entry, coordinating resolution of all data queries. Completing data entry as warranted
Complying with all institutional policies and government regulations pertaining to human subject protections. Maintaining regulatory binders, case report forms, source documents, and other study documents. Monitoring the occurrence of clinical adverse events, reporting any to the PI, the study sponsor, and Institutional Review Board (IRB)
Assisting with IRB requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting, and annual reviews
Performing basic laboratory activities as needed
Maintaining patient confidentiality in accordance with HIPAA regulations and keeping study information in a safe and secure location. Consistently adheres to FDA Good Clinical Practice Guidelines
Identifying and resolving problems with protocol compliance by notifying the PI and as necessary with the protocol sponsor
Arranging necessary tests and procedures in accordance with protocol requirements and reports results to the PI
Performing necessary tests as needed and as appropriate to level of training
Organizing and participating in site visits with the study sponsor to review completeness and accuracy of study documentation
Maintaining inventory of all study supplies
Other duties as assigned by supervisor
Qualification
Required
Minimum of two years of experience in research-related activities
High degree of organizational talents
Data collection and analysis skills
Meticulous attention to detail
Computer skills at the advanced level
Ability to prioritize quickly and appropriately
Excellent communication and interpersonal skills
Care in organization and systematic record keeping
Bachelor's Degree or relevant experience in lieu of degree
An equivalent combination of education and experience, which provides proficiency in the areas of responsibility listed above, may be substituted for the above education and experience requirements
Company
Maine Eye Center
Maine Eye Center provides comprehensive eye specialty services with the help of trained optometrists and physicians.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase