Overview
Contractual Clinical Research Associate (cCRA) with experience in dermatology. The cCRA will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Responsibilities
* Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Indero and sponsor SOPs, ICH/CGP guidelines and applicable regulations
* Participates in investigators’ meetings
* Prepares site visit reports and follow-up letters to the investigator
* Builds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets
* Performs source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate
* Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training
Requirements
Education
* B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
Experience
* 3 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry
* At least 1 year of experience in dermatology
Knowledge And Skills
* Good knowledge of ICH/GCP standards and applicable regulatory requirements
* Strong verbal and written communication skills in English
* Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines
* Excellent judgement and problem-solving skills
* Travel to research sites approximately 65% of the time
* Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint)
* Experience in dermatology is an asset
About Indero
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
EEO Statement
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in UK.
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