- Facilitate and coordinate daily activities related to clinical trials, playing a pivotal role in the study's execution.
- Administer sponsor-mandated questionnaires, such as VFQ.
- Collaborate with team members responsible for procuring study supplies, ensuring sufficient inventory availability.
- Ensure proper training of study staff on pertinent information (e.g., protocol, ICF, manuals) and meticulously document the training process.
- Create, manage, and upkeep source documents for each trial.
- Attend teleconferences and Investigator Meetings as directed by the research director.
- Review and comprehend study protocols, including proceedings, timelines, inclusion/exclusion criteria, confidentiality, and privacy protections.
- Collaborate with study and clinical teams to recruit eligible candidates, meeting enrollment goals.
- Screen subjects for eligibility using protocol-specific criteria, accurately documenting each potential participant's eligibility.
- Efficiently complete delegated study tasks, such as scribing, VFQ, IOP, etc.
- Collect updated medical history, adverse events, and serious adverse events for timely reporting to the sponsor and IRB.
- Conduct or participate in the informed consent process/discussion with research participants, addressing any study-related queries.
- Ensure proper implementation and signing of amended consent forms.
- Act as a secondary reviewer to oversee accurate execution of the ICF process.
- Collect and enter protocol-required data into the electronic data capture (EDC) system within specified timeframes.
- Oversee data entry accuracy and promptly resolve any queries within required timelines.
- Collect and report all Adverse Events and Serious Adverse Events.
- Ensure acknowledgment and review of all SUSAR/Safety Reports.
- Coordinate monitor site visits and assist in preparing site visit documentation.
- Collaborate with monitors to make necessary corrections to meet requirements and deadlines.
- Manage and maintain all regulatory information for the study, including the protocol, investigator brochure, IRB documents, investigator disclosures, CVs, training documentation, and instructions on reporting requirements for the IRB and the sponsor.
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Clinical Research Coordinator - Wildwood, United States - Medix
Description
Clinical Research Coordinator Opportunity in Wildwood, FL
**Previous Clinical Research Experience is required**
Overview of Responsibilities:
The role of the research coordinator entails the coordination of research patient visits in adherence to both ICH-GCP guidelines and the IRB-approved study protocol and/or manual of procedures. Daily activities encompass a range of essential functions, contingent upon individual expertise and the evolving needs of the organization.
Roles and Duties:
Additional Details:
Location:Wildwood, FL
Pay:$50,000-$70,000 Annual Salary (Dependent on background and Years of experience)
Hours: Monday - Friday; Normal Business Hours (Onsite 5 Days a Week)
Duration: ~6 month Contract to Hire (~1,040 hours) - contracted probationary period into direct hire/permanent position
Requirements: Previous Clinical Research experience - Ideally 2+ Years of experience as a Clinical Research Coordinator; Ophthalmology/Retina Experience
