Clinical Research Associate Duties & Responsibilities 1
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Clinical Research Associate Requirements & Skills 1
Clinical Research Associate Job summary 2
We are looking for a Clinical Research Associate to join our Clinical Operations department. You will be responsible for site identification and assisting with the distribution and collection of essential documents in accordance with the SOP and ICH-GCP. You will support submissions to local regulatory authorities, localisation of patient-facing materials and assembly of the Investigator Site File.
Clinical Research Associate Duties & Responsibilities 2
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Clinical Research Associate Requirements & Skills 2
Clinical Research Associate Job summary 3
A Clinical Research Associate will coordinate multiple complex clinical trial studies independently. Will manage multiple patients enrolled in clinical trial studies and guide them through study visits while overseeing all aspects of the clinical trial process which includes: manage and handle laboratory supplies and data; participate in subject identification and recruitment; oversee the consent process; gather, transcribe, and enter study data into sponsor databases; gather and handle biospecimens; create source documents to collect study data; ensure quality control, compile reports for regulatory compliance and maintenance while complying with clinical trial study requirements.
The Clinical Research Associate will also troubleshoot to avoid protocol deviations. Will complete all training requirements for each study, attend study meetings as necessary, and participate in monitoring visits and audits. Completion and maintenance of all regulatory documentation (startup packets, training, logs, amendments, continuing reviews).
Clinical Research Associate Duties & Responsibilities 3
Clinical Research Associate Requirements & Skills 3
Clinical Research Associate Job summary 4
The Clinical Research Associate is responsible for supporting in-house testing of R&D prototype instruments. The Clinical Research Associate may also assist with training external clinical study sites on the use of prototype and commercially available instrumentation.
The Clinical Research Associate may assist with the planning and execution of beta studies, including preparation of beta plans, beta protocols, and final beta reports. The Clinical Research Associate may participate as a member of Project Teams, as assigned, representing the Clinical/Regulatory Affairs department.
Clinical Research Associate Duties & Responsibilities 4
Clinical Research Associate Requirements & Skills 4
Clinical Research Associate Job summary 5
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical Research Associate, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Clinical Research Associate Duties & Responsibilities 5
Clinical Research Associate Requirements & Skills 5
Clinical Research Associate Job summary 6
The Clinical Research Associate (CRA) has an important task within the clinical trial process. He or she has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data is accurate, complete, and verifiable from source documents. Most importantly, the CRA makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements. This is an exempt position that directly reports to the Cheif Medical Officer.
Clinical Research Associate Duties & Responsibilities 6
Clinical Research Associate Requirements & Skills 6
Clinical Research Associate Job summary 7
We are recruiting for a new Clinical Research Associate to join our Clinical Affairs team. In this role, you will be involved in designing, executing, and monitoring of internal and external clinical studies in support of our products and pipeline. Your efforts in this manner will adopt, adhere and follow standard procedures in executing experiments, evaluations and documentation and reporting of results / findings. You should be a steward of quality and excellence. Successful and timely completion of clinical studies directly impacts the ability to meet product development goals and product introduction timelines.
Clinical Research Associate Duties & Responsibilities 7
Clinical Research Associate Requirements & Skills 7