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Clinical Research Associate
2 months ago
We are seeking a dedicated Research Support Specialist to enhance our dynamic team at Medix™. This is a full-time, onsite opportunity that comes with a competitive salary, potential bonuses, and an extensive benefits package. If you are eager to be part of a national organization that offers significant growth opportunities, this position may be ideal for you.
Position Overview
The Research Support Specialist plays a crucial role in facilitating patient research visits in accordance with ICH-GCP standards and the approved study protocols. Daily responsibilities may encompass various essential functions, tailored to individual expertise and the organization's evolving needs.
Qualifications:
- High School diploma or equivalent, with substantial relevant experience
- Preferred: College degree
Skills and Experience:
- Strong oral and written communication abilities
- Commitment to delivering safe and appropriate patient care as per study protocols
Key Responsibilities
- Assist the Coordinator with Clinical Trial Management System (CTMS) operations
- Address and resolve data management inquiries as necessary
- Inform participants and secure written consent regarding Informed Consent Forms (ICFs) for selected studies
- Support and observe ocular examinations conducted by physicians, ensuring proper treatment adherence per protocol
- Submit necessary images to Clinical Research Coordinators (CRCs)
- Assist with unmasked responsibilities for Investigator-Sponsored Trials (ISTs) and Phase 1 studies, including maintaining investigational product and shipping logs
- Conduct Serious Adverse Event reporting, including initial and follow-up documentation, and promptly request all required medical records
- Gain knowledge in regulatory compliance and assist the Coordinator in managing regulatory affairs, including training and monitoring visits
- Transcribe and resolve queries related to subject study information from source documents to Electronic Case Report Forms
- Coordinate and schedule participant visits in accordance with study-specific timelines
- Prepare visit-specific documentation and charts for the Clinical Research Coordinator
- Observe and assist the Coordinator in patient care and management
- Monitor subject flow and provide assistance in subject care
- Collect and document all necessary data during follow-up study visits (Phase 2 & 3; excluding Gene Therapy)
- Administer mandatory questionnaires to study participants
- Set up, prepare subjects, and conduct electrocardiograms (ECGs) as required by the study protocol
