Clinical Research Associate | Alabama, Louisiana, Mississippi - REMOTE
clinical research research remote monitoring manager clinical research research protocol compliance procedures manages collaboration close out
September 2, 2022
- Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with International Council for Harmonisation Good Clinical Practice (ICH-GCP), Sponsor Standard Operating Procedures (SOPs), Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates and provides inputs on site selection and validation activities.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits, and records clear, comprehensive, and accurate visit and non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per defined Clinical Research Associate (CRA) Escalation Pathway as appropriate in collaboration with Clinical Research Manager (CRM), Partner Line Manager (PLM) and Regional Clinical Project Manager (RCPM).
- Manages and maintains information and documentation in Clinical Trial Management System (CTMS), Trial Master File (eTMF) and various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME) , buddy/mentor and sharing best practices as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Performs remote and on-site monitoring and oversight activities using various tools to ensure; 1) Data generated at site are complete, accurate and unbiased and 2) Subjects’ right, safety and well-being are protected
- Bachelor of Arts or Science Degree preferred with a strong emphasis in science and/or biology
- Min. 2 years of direct site monitoring experience in a bio/pharma/ Clinical Research Organization (CRO) (or as country specifically requires)
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