Clinical Research Associate I
O
OraOphthalmic clinical research
Remote- United KingdomFull-TimeEntry
Salary not disclosed
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Job Details
- Experience
- 1 years’ experience in the clinical research field
- Required Skills
- Microsoft Excel
Requirements
- Bachelor's degree with 1 years’ experience in the clinical research field or equivalent combination of education, training and experience.
- Ophthalmic experience strongly preferred.
- Capacity to routinely assess protocol and GCP compliance.
- Demonstrated ability to verify source data to reported data.
- Strong attention to detail in order to review completeness of the investigator site file.
- Knowledge to reconcile and return/destroy test article while conducting initiation, interim, and close-out visits.
- Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
- Ability to read and demonstrate a comprehension of a clinical research protocol as well as understand the importance of following the protocol.
- Proficiency with Excel, CTMS and EDC.
- Multilingual communication is a plus.
Responsibilities
- Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gain in-depth understanding of the study protocol and related procedures.
- Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
- Participate & provide input on site selection and validation activities.
- Perform remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased, Subjects’ right, safety and well-being are protected
- Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
- Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Supports audit/inspection activities as needed.
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