Clinical Research and Study Coordinator

Maine Eye Center•Portland, ME

3d•Onsite

About The Position

Maine Eye Center’s vision is to be the preferred regional ophthalmology practice for comprehensive medical and surgical eye care. Our mission is to consistently provide high quality eye care and outcomes through excellent service, exceptional doctors, staff, and state-of-the-art technology. Maine Eye Center Core Values include Teamwork, Quality Patient Care, Respect, Responsibility, and Integrity. The Clinical Research Coordinator II will assist the Principal Investigator (PI) in implementing clinical research studies as assigned. The CRC II will provide assignments and schedules to team members and monthly updates to the Clinical Director. This position acts as the primary point of contact for Investigators on proposed clinical trials. This position works normal business hours Monday-Friday 8:00 a.m. – 5:00 p.m. Flexibility in the schedule is needed from time to time to meet business goals and provide exceptional patient service.

Requirements

Minimum of two years of experience in research-related activities. High degree of organizational talents, data collection, and analysis skills are required. Meticulous attention to detail, computer skills at the advanced level, ability to prioritize quickly and appropriately, excellent communication and interpersonal skills, as well as 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.

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.