Clinical Research Coordinator

Description

CLINICAL RESEARCH COORDINATOR

Job description

Job Description

Lead Clinical Research Coordinator APG RESEARCH, LLC - Orlando, FL

General Description APG RESEARCH LLC, is looking for an experienced Lead Clinical Research Coordinator (CRC) who can support, facilitate and coordinate the daily clinical trial activities in accordance with the study and manage participant recruitment. While performing these duties, the Lead CRC will work with the PI, the CRC, Associate Director for Research and Sponsor(s), to support and provide guidance on the administration of the compliance, personnel, and other related aspects of the clinical study, while also managing other study personnel.

Requirements

Please DO NOT apply if you do not have the minimum 2 years of direct relevant clinical research experience.

*Experience in Phlebotomy and PK Evaluations for Children and Adults- IS A PLUS! Medical Assistant Degree and 2+ years directly relevant clinical research experience preferred but not required.

The lead research coordinator shall meet the eligibility requirements for certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals. Within a reasonable period after certification becomes available, certification will be considered an essential requirement. Two (2) years' experience in a clinical research setting required. NO traveling is required.

Requirements

Responsibilities

• Informed consent collection and verification process.
• Data collection and verification, identify errors and inconsistencies in CRF data and ensure their resolution.
• IRB deviation submission, and work to create process improvements to ensure quality of data.
• Phlebotomy and lab specimen processing.
• Investigational Product dispensation and accountability.
• Medical record review and verification.
• Involved in protocol, informed consent, and study specific source development.
• Assist with study start up activities such as regulatory documentation, patient identification and recruitment planning.
• Identify potential risks to the enrollment targets based on feasibility analysis in collaboration with management.
• Provide timely and professional study closings and performed ongoing management of clinical data.
• Prepare material for presentation at study protocol training meetings.
• Reconciliation of serious adverse events and external data in order that databases can be declared audit ready according to strict quality standards.
• Assist in the Medical and Regulatory Document Review, tabulation of clinical data (excel spreadsheets), and writing of Clinical Study Reports (CSR's).
• Support and Train on computer software programs. For example, I Medidata, Inform, and Data-Labs.
• Troubleshoot any computer related issues with hardware and software programs.
• Oversee day to day clinic activities including ensuring staffing requirements are sufficient and maintaining adequate clinic flow.
• Maintain essential staff documents (CVs, licenses, site laboratory certifications) and coordinate Human Protections Training for personnel.